Generic Drug User Fees

GDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROGRAM
ENHANCEMENTS FISCAL YEARS 2023-2027
I. SUBMISSION ASSESSMENT PERFORMANCE GOALS
A. Original ANDAs and Amendments
B. PASs and PAS Amendments
C. Unsolicited Amendments and PAS Amendments
D. DMFs
E. Controlled Correspondence
II. ORIGINAL ANDA ASSESSMENT PROGRAM ENHANCEMENTS
A. ANDA Receipt
B. ANDA Assessment Transparency and Communications Enhancements
C. Assessment Classification Changes During the Assessment Cycle
D. ANDA Approval and Tentative Approval
E. Dispute Resolution
F. Pre-Submission Facility Correspondence
G. Other ANDA Assessment Program Aspirations
III. PRE-ANDA PROGRAM
A. Goal of Pre-ANDA Program
B. Suitability Petitions
C. Product-Specific Guidance
D. Product Development Meetings
E. Pre-Submission Meetings
IV. ANDA ASSESSMENT MEETING PROGRAM
A. Goal of the ANDA Assessment Meeting Program
B. Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings

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C. Post-CRL Scientific Meeting
V. ADDITIONAL PROGRAM ENHANCEMENTS AND ASPIRATIONS
A. Inactive Ingredient Database Enhancement
B. Regulatory Science Enhancements
C. Other Pre-ANDA and Assessment Meeting Program Aspirations
VI. DMF ASSESSMENT PROGRAM ENHANCEMENTS
A. Communication of DMF Assessment Comments
B. Teleconferences to Clarify DMF First Cycle Assessment Deficiencies
C. DMF First Adequate Letters
D. DMF No Further Comment Letters
E. DMF Review Prior to ANDA Submission
F. FDA Assessment of Solicited DMF Amendments
G. FDA Communication Related to DMF Amendments and ANDAs
VII.

FACILITIES
A. Foreign Regulators
B. Communication Regarding Inspections
C. GDUFA III Inspection Classification Database
D. Post-Warning Letter Meetings
E. Generic Drug Manufacturing Facility Re-inspection

VIII.

CONTINUED ENHANCEMENT OF USER FEE RESOURCE MANAGEMENT
A. Sustainability of GDUFA Program Resources
B. Resource Capacity Planning
C. Resource Capacity Planning Assessment
D. Financial Transparency and Efficiency

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E. Improving the Hiring of Review Staff
IX. GUIDANCE AND MAPPS
X. PERFORMANCE REPORTING
A. Monthly Reporting Metrics
B. Quarterly Reporting Metrics
C. Fiscal Year Performance Report Metrics
D. Fiscal Year Web Posting
XI. DEFINITIONS

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GDUFA REAUTHORIZATION PERFORMANCE GOALS AND
PROGRAM ENHANCEMENTS FISCAL YEARS 2023-2027
This document contains the performance goals and program enhancements for the Generic Drug
User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, known as
GDUFA III. It is commonly referred to as the “Goals Letter” or “Commitment Letter.” The
Goals Letter represents the product of the Food and Drug Administration’s (FDA or the Agency)
discussions with the regulated industry and public stakeholders, as mandated by Congress. The
performance goals and program enhancements specified in this letter apply to aspects of the
generic drug assessment program and build on the GDUFA program established and enhanced
through previous authorizations. New enhancements to the program are designed to maximize
the efficiency and utility of each assessment cycle, with the intent to reduce the number of
assessment cycles for abbreviated new drug applications (ANDAs) and facilitate timely access to
quality, affordable, safe and effective generic medicines. Certain new enhancements are
specifically designed to foster the development, assessment, and approval of Complex Generic
Products. FDA is committed to meeting the performance goals specified in this letter and to
continuous improvement of the Agency’s performance.
GDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES
FISCAL YEARS 2023-2027
The performance goals and procedures of FDA, as agreed to under the third authorization of the
generic drug user fee program, are summarized below.
Unless otherwise stated, goals apply to cohorts of each fiscal year. For the purposes of
calculating all time periods in this Commitment Letter, FDA will calculate the goal date from the
day after a submission, to be consistent with FDA’s other user fee programs.
I. SUBMISSION ASSESSMENT PERFORMANCE GOALS
A. Original ANDAs and Amendments
1. Assess and act on 90 percent of standard original ANDAs within 10 months of the
date of ANDA submission, subject to any adjustments to the goal dates described in
section I(A)(3).
2. Assess and act on 90 percent of priority original ANDAs within the applicable
assessment goal, subject to any adjustments to the goal dates described in section
I(A)(3).

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a. Assess and act on priority original ANDAs within 8 months of the date of ANDA
submission if the applicant submits a Pre-Submission Facility Correspondence
(PFC) not later than 60 days prior to the date of ANDA submission, and the PFC
is found to be complete and accurate, subject to the limitations set forth in section
I(A)(2)(b).
b. Assess and act on priority original ANDAs within 10 months of the date of
ANDA submission if:
i.

the applicant submits a PFC later than 60 days prior to the date of ANDA
submission, or does not submit a PFC;

ii.

information in a PFC is found to be incomplete or inaccurate;

iii.

the information submitted in the ANDA differs significantly from what was
submitted in the PFC; or

iv.

FDA, upon assessment of a final bioequivalence study report submitted in the
ANDA, determines that an inspection of the relevant site or sites is necessary.

3. If, upon initial submission, a standard or priority original ANDA contains a
certification that a site/facility listed on the Form FDA 356h is not ready for
inspection (i.e., the box “no” is checked in response to “is the site ready for
inspection?” in section 28), FDA will set a goal date that is 15 months from the date
of submission. FDA will conduct a filing review of such an ANDA but will not
commence substantive assessment of the application until an amendment described in
subsection I(A)(3)(a) is submitted, or the goal date is reset pursuant to I(A)(3)(b).
a. During the initial 15-month review period, if the applicant submits an amendment
with a Form FDA 356h that certifies all facilities are ready for inspection, FDA
will set a new goal date that is 8 months from the date of submission for priority
amendments (if a PFC was submitted per I(A)(2)(a)), or 10 months from the date
of submission for other amendments.
b. If the applicant does not submit an amendment described in I(A)(3)(a) by 30 days
before the goal date, FDA will reset the goal date for an additional 15 months, i.e.,
30 months from the date of original ANDA submission. FDA will assess and act
on 90 percent of such ANDAs within 30 months of the date of the original
submission as applicable.
4. Assess and act on 90 percent of standard Major Amendments within the applicable
assessment goal.

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a. Assess and act on standard Major Amendments within 8 months of the date of
amendment submission if preapproval inspection is not required.
b. Assess and act on standard Major Amendments within 10 months of the date of
amendment submission if preapproval inspection is required.
5. Assess and act on 90 percent of priority Major Amendment submissions within the
applicable assessment goal.
a. Assess and act on priority Major Amendments within 6 months of the date of
amendment submission if preapproval inspection is not required.
b. Assess and act on priority Major Amendments within 8 months of amendment
submission if a preapproval inspection is required, the applicant submits a PFC
not later than 60 days prior to the date of amendment submission, and the PFC is
found to be complete and accurate, subject to the limitations set forth in section
I(A)(6).
6. Assess and act on priority Major Amendments within 10 months of amendment
submission if a preapproval inspection is required and if:
a. the applicant submits a PFC later than 60 days prior to the date of the amendment,
or does not submit a PFC;
b. information in a PFC is found to be incomplete or inaccurate;
c. the information submitted in the amendment differs significantly from what was
submitted in the PFC; or
d. FDA, upon assessment of a final bioequivalence study report submitted in the
amendment, determines that an inspection of the relevant site or sites is necessary.
7. Assess and act on 90 percent of standard and priority Minor Amendments within 3
months of the date of amendment submission.

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Table for Section I(A)(1) and (2): Original ANDAs
Submission Type
Standard Original ANDAs
Priority Original ANDAs

Goal
90% within 10 months of submission date, subject to
any adjustment to the goal date described in section
I(A)(3).
90% within 8 months of submission date if applicant
meets requirements under section I(A)(2)(a), subject
to any adjustment to the goal date described in
section I(A)(3).
90% within 10 months of submission date if applicant
meets any limitations as described under section
I(A)(2)(b), subject to any adjustment to the goal date
described in section I(A)(3).

Table for Section I(A)(4) – (7): Amendments
Submission Type
Standard Major Amendments

Priority Major Amendments

Standard and Priority Minor
Amendments

Goal
90% within 8 months of submission date if preapproval
inspection not required.
90% within 10 months of submission date if
preapproval inspection required.
90% within 6 months of submission date if preapproval
inspection not required.
90% within 8 months of submission date if preapproval
inspection required and applicant meets requirements
under section I(A)(5)(b).
90% within 10 months of submission date if
preapproval inspection required and applicant meets
any limitations as described under section I(A)(6).
90% within 3 months of submission date.

B. PASs and PAS Amendments
1. Assess and act on 90 percent of standard prior approval supplements (PASs) within
the applicable assessment goal.
a. Assess and act on standard PASs within 6 months of the date of PAS submission
if preapproval inspection is not required.

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b. Assess and act on standard PASs within 10 months of the date of PAS submission
if preapproval inspection is required.
2. Assess and act on 90 percent of priority PASs within the applicable assessment goal.
a. Assess and act on priority PASs within 4 months of the date of PAS submission if
preapproval inspection is not required.
b. Assess and act on priority PASs within 8 months of the date of PAS submission if
a preapproval inspection is required, the applicant submits a PFC not later than 60
days prior to the date of PAS submission, and the PFC is found to be complete
and accurate, subject to the limitations set forth in section I(B)(2)(c).
c. Assess and act on priority PASs within 10 months of PAS submission if a
preapproval inspection is required and if:
i.

the applicant submits a PFC later than 60 days prior to the date of PAS
submission, or does not submit a PFC;

ii.

information in a PFC is found to be incomplete or inaccurate;

iii.

the information submitted in the PAS differs significantly from what was
submitted in the PFC; or

iv.

FDA, upon assessment of a final bioequivalence study report submitted in the
PAS, determines that an inspection of the relevant site or sites is necessary.

3. Assess and act on 90 percent of Major Amendments to standard PASs within the
applicable assessment goal.
a. Assess and act on Major Amendments to standard PASs within 6 months of the
date of amendment submission if preapproval inspection is not required.
b. Assess and act on Major Amendments to standard PASs within 10 months of the
date of amendment submission if preapproval inspection is required.
4. Assess and act on 90 percent of Major Amendments to priority PASs within the
applicable assessment goal.
a. Assess and act on Major Amendments to priority PASs within 4 months of the
date of amendment submission if preapproval inspection is not required.

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b. Assess and act on priority Major Amendments to priority PASs within 8 months
of amendment submission if a preapproval inspection is required, if the applicant
submits a PFC not later than 60 days prior to the date of amendment submission,
and the PFC is found to be complete and accurate, subject to the limitations set
forth in section I(B)(4)(c).
c. Assess and act on priority Major Amendments to priority PASs within 10 months
of amendment submission if a preapproval inspection is required and if:
i.

the applicant submits a PFC later than 60 days prior to the date of the PAS
amendment, or does not submit a PFC;

ii.

information in a PFC is found to be incomplete or inaccurate;

iii.

the information submitted in the PAS amendment differs significantly from
what was submitted in the PFC; or

iv.

FDA, upon assessment of a final bioequivalence study report submitted in the
amendment, determines that an inspection of the relevant site or sites is
necessary.

5. Assess and act on 90 percent of Minor Amendments to standard and priority PASs
within 3 months of the date of amendment submission.
Table for Section I(B)(1) and (2): PASs
Submission Type
Standard PASs

Priority PASs

Goal
90% within 6 months of submission date if preapproval
inspection not required.
90% within 10 months of submission date if
preapproval inspection required.
90% within 4 months of submission date if preapproval
inspection not required.
90% within 8 months of submission date if preapproval
inspection required and applicant meets requirements
under section I(B)(2)(b).
90% within 10 months of submission date if
preapproval inspection required and applicant meets
any limitations as described under section I(B)(2)(c)

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Table for Section I(B)(3) – (5): PAS Amendments
Submission Type
Standard PAS Major Amendments

Priority PAS Amendments

Standard and Priority Minor PAS
Amendments

Goal
90% within 6 months of submission date if preapproval
inspection not required.
90% within 10 months of submission date if
preapproval inspection required.
90% within 4 months of submission date if preapproval
inspection not required.
90% within 8 months of submission date if preapproval
inspection required and applicant meets requirements
under section I(B)(4)(b).
90% within 10 months of submission date if
preapproval inspection required and applicant meets any
limitations as described under section I(B)(4)(c).
90% within 3 months of submission date.

C. Unsolicited Amendments and PAS Amendments
1. Assess and act on Unsolicited Amendments and PAS amendments submitted during
the assessment cycle by the later of the goal date for the original submission/solicited
amendment or the goal date assigned in accordance with sections (I)(A)(4), (5), (6)
and (7) and (I)(B)(3), (4) and (5), respectively, for the Unsolicited Amendment.
2. Assess and act on Unsolicited ANDA Amendments and PAS amendments submitted
between assessment cycles by the later of the goal date for the subsequent solicited
amendment or the goal date assigned in accordance with sections (I)(A)(4), (5), (6),
and (7) and (I)(B)(3), (4), and (5), respectively, for the Unsolicited Amendment.
D. Drug Master Files (DMFs)
Complete the initial completeness assessment for 90 percent of Type II active
pharmaceutical ingredient (API) DMFs within 60 days of the later of the date of DMF
submission or DMF fee payment.
Table for Section I(D): DMFs
Submission Type
Type II API DMF

Goal
90% of initial completeness assessments within 60 days
of the later of the date of DMF submission or DMF fee
payment.

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E. Controlled Correspondence
1. A Controlled Correspondence may be submitted by or on behalf of a generic drug
manufacturer or related industry prior to ANDA submission. Under the GDUFA II
framework, correspondence seeking regulatory and/or scientific advice after issuance
of a Complete Response Letter (CRL) or tentative approval, or after ANDA approval,
was considered general correspondence. Under GDUFA III, these types of
correspondence can be submitted as Controlled Correspondence. During an ANDA
assessment cycle, a Controlled Correspondence may only be submitted if an applicant
seeks further feedback from FDA after a product-specific guidance (PSG)
Teleconference, as described in section III(C)(5)(c), below, or to seek a Covered
Product Authorization. During an ANDA assessment cycle, all other correspondence
will be general correspondence.
2. Review and respond to 90 percent of Controlled Correspondence within the
applicable review goal.
a. Review and respond to Level 1 Controlled Correspondence within 60 days of the
date of submission.
b. Review and respond to Level 2 Controlled Correspondence within 120 days of the
date of submission.
3. FDA will review and respond to 90 percent of submitter requests to clarify
ambiguities in the Controlled Correspondence response within 21 days of receipt of
the request. The response to the submitter’s request will provide clarification or
advice concerning the ambiguity in the Controlled Correspondence response.

Table for Section I(E): Controlled Correspondence
Submission Type
Level 1 Controlled Correspondence

Goal
90% within 60 days of submission date.

Level 2 Controlled Correspondence

90% within 120 days of submission date.

FDA will review and respond to 90% of submitter requests to clarify ambiguities in the
Controlled Correspondence response within 21 days of request receipt.

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II. ORIGINAL ANDA ASSESSMENT PROGRAM ENHANCEMENTS
A. ANDA Receipt
1. FDA will strive to determine whether to receive ANDAs within 60 days of the date of
ANDA submission.
2. To enable FDA to rapidly determine whether to receive an ANDA pursuant to 21
CFR 314.101, and with consideration of final Agency guidances that address ANDA
receipt determinations, FDA will communicate minor technical deficiencies (e.g.,
document legibility) and deficiencies potentially resolved with information in the
ANDA at original submission within 10 days of original ANDA submission. If a
deficiency is resolved within 10 days, that deficiency will not be a basis for a refuseto-receive decision.
3. At the time of receipt, FDA will notify the applicant in the acceptance letter whether
the ANDA or PAS is subject to priority or standard assessment.
B. ANDA Assessment Transparency and Communications Enhancements
To promote transparency and communication between FDA and ANDA applicants, FDA
will apply the assessment program enhancements below to the assessment of all ANDAs.
The goal of these program enhancements is to improve predictability and transparency,
promote the efficiency and effectiveness of the review process, minimize the number of
assessment cycles necessary for approval, increase the overall rate of approval, and
facilitate greater access to generic drug products.
1. Information Requests (IRs) and Discipline Review Letters (DRLs):
a. IRs and DRLs do not stop the assessment clock.
b. In the first assessment cycle, FDA will issue the appropriate IR(s) and/or DRL(s)
from each assessment discipline by the mid-point of the assessment, with the
exception of the Labeling discipline as described in subsection II(B)(2) below.
i. In a Mid-Cycle DRL, the assessment discipline will assign a due date for
response and identify major and minor deficiencies.
ii. If an applicant responds by the response due date, FDA will assess a response
to minor deficiencies within the originally assigned goal date for the
submission, subject to the exceptions described in II(B)(1)(iii).

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iii. Responses to any major deficiencies, or to minor deficiencies that include data
and information that require comparable FDA assessment resources to those
required for major deficiencies, for example, a consult, will be considered
Major Amendments. FDA will extend the goal date consistent with the
number of months needed to assess a comparable standard or priority Major
Amendment (see section I(A)(4)-(6)).
c. FDA will issue IRs and DRLs after the midpoint of the first assessment cycle and
at any time in subsequent assessment cycles, when, in FDA’s judgment, there are
one or more minor deficiencies in a discipline that, if resolved using an IR or
DRL, could lead to approval or tentative approval of an ANDA in the current
assessment cycle. FDA will issue the IR or DRL and provide a due date for the
applicant’s response before the goal date.
i. If the applicant responds to the minor deficiencies in the IR or DRL by the
due date, and FDA finds the amendment to satisfactorily address all of the
issues identified in the IR or DRL, and the response does not contain
unsolicited information, FDA may extend the goal date by 90 days from the
date of the applicant’s response.
ii. FDA’s decision to extend the goal date will be communicated in an
amendment acknowledgement letter.
iii. FDA will continue to issue IRs and/or DRLs late in the assessment cycle for
original submissions and amendments until it is no longer feasible within the
current assessment cycle for the applicant to develop and FDA to assess a
response to the IR and/or DRL. For IRs and DRLs issued past the mid-point
of the assessment cycle, the assessment discipline generally will assign a due
date for response and identify major and minor deficiencies. DRLs issued
without a response due date likely will signify a forthcoming CRL.
d. If the applicant does not provide a complete response to an IR and/or DRL by the
response due date (or any agreed-upon extension), FDA may include the same
deficiencies from the IR or DRL in a CRL and assess the response during the next
assessment cycle.
e. If a discipline identifies a Significant Major deficiency, that deficiency will be
communicated in a CRL as soon as is feasible.

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2. Specific commitments related to IRs and DRLs for labeling:
a. In the first assessment cycle, the Labeling Discipline will:
i. upon receiving an ANDA for assessment, make an initial determination
whether there is a need for a consult to be issued to another review discipline,
including for a consult regarding an applicant’s request to “carve out”
language in the proposed labeling protected by patents or exclusivities, and
will initiate such consults;
ii. strive to issue any DRL at approximately months 6-7 of the assessment for
those ANDAs with a 10-month goal date, or months 5-6 of the assessment for
those ANDAs with an 8-month goal date, with the exception that there may be
a delay of the issuance of any labeling deficiencies that result from changes to
the labeling of the reference listed drug (RLD) or a new exclusivity or patent
listing;
iii. limit the assessment of labeling to one IR/DRL if other disciplines will not be
acceptable during the first cycle; and
iv. continue to assess labeling to enable an action within the assessment cycle if
other disciplines are acceptable.
b. Labeling IRs and DRLs in all assessment cycles:
FDA will minimize issuing CRLs that contain only labeling deficiencies by, for
example, utilizing later-cycle IRs and the imminent action process.
3. Imminent Actions:
a. FDA will continue assessment of an ANDA past the goal date if, in FDA’s
judgment, it may be possible to approve or tentatively approve an ANDA within
60 days after the goal date. Such circumstances may include:
i. When the application meets the requirements for tentative approval by the
goal date, but the legally permissible ANDA approval date is within 60 days
after the goal date, and FDA may be able to approve the ANDA when it
becomes legally permissible to do so.
ii. When FDA may be able to approve or tentatively approve an application
submitted by a first applicant by the 30-month forfeiture date described in
section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(j)(5)(D)(i)(IV)).

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iii. When, at the sole discretion of FDA, and subject to resources, one or more
small issues remain from one or more disciplines that in FDA’s judgment may
be resolved within 60 days after the goal date.
b. If an ANDA is approved or tentatively approved within 60 days after the goal
date, the goal date will be considered to have been met.
4. FDA will strive to act prior to a goal date, or the 60-day period for an imminent
action, when the assessment is complete and there are no outstanding deficiencies.
5. To facilitate the labeling assessment, an applicant will clearly state in the cover letter
to an ANDA, amendment, PAS, or PAS Amendment that the submission includes a
proposed labeling carve-out.
6. Communication regarding Deficiencies and Actions:
a. With respect to imminent actions, applicants may inquire and FDA will promptly
respond to an applicant inquiry seeking information as to whether FDA intends to
work through the goal date in accordance with section II(B)(3). This
communication will be preliminary and subject to change.
b. If a regulatory project manager (RPM) learns that a major deficiency is likely
forthcoming, the RPM will notify the applicant. The RPM will not be expected to
discuss the nature of the specific forthcoming deficiencies prior to issuance of the
CRL.
c. If an RPM learns that FDA is likely to miss the goal date for an ANDA, the RPM
will notify the applicant of the delay in taking an action, identify the general
reason for the delay including the outstanding discipline(s), if any, and the
estimated time for FDA’s action on the application.
d. The applicant may periodically request a Review Status Update for each
discipline. In response to the applicant’s request, the RPM will timely provide a
Review Status Update for each discipline.
7. FDA will indicate the assessment classification for a responding amendment in a
CRL and include FDA’s basis for classifying a responding amendment as Major.

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8. Applicants who receive a CRL have the following options with respect to engaging
with FDA prior to responding to the CRL:
a. A post-CRL teleconference to seek clarification concerning deficiencies identified
in a CRL. FDA will grant appropriate requests for teleconferences requested by
applicants upon receiving first-cycle CRLs and upon receiving subsequent CRLs.
An appropriate request is one that clearly identifies the specific deficiencies to be
discussed and the reason why such deficiencies are not clear. FDA will provide a
scheduled date for 90 percent of post-CRL teleconferences within 14 days of the
request for a teleconference and conduct 90 percent of such post-CRL
teleconferences, if granted, within 30 days of receipt of the written request;
b. Submission of a Controlled Correspondence as described in section I(E); or
c. A post-CRL Scientific Meeting to request scientific advice on possible
approaches to address deficiencies identified in a CRL related to establishing
equivalence, subject to the conditions described in section IV(C).
C. Assessment Classification Changes During the Assessment Cycle
1. If during the assessment of an ANDA, ANDA amendment, PAS, or PAS amendment,
the assessment classification changes from Standard to Priority, FDA will notify the
applicant within 14 days of the date of the change.
2. An applicant may request a change in the assessment classification at any time during
the assessment.
3. Once an ANDA or PAS submission is classified as being subject to priority
assessment, the application will retain such priority assessment classification status
for the duration of that assessment cycle.
4. FDA will include an explanation of the reasons for any denial of an assessment status
reclassification request.
5. If an applicant requests a teleconference as part of its request to reclassify a Major
Amendment or standard assessment status, FDA will schedule and conduct the
teleconference and decide 90 percent of such reclassification requests within 30 days
of the date of FDA’s receipt of the request for a teleconference. This goal only applies
when the applicant accepts the first scheduled teleconference date offered by FDA.
This goal does not apply to a Major Amendment in response to a CRL that was
deemed major only due to a facility deficiency (“Facility-Based Major CRL
Amendment”) described in section II(C)(7).

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6. An amendment in response to a CRL classified by FDA as Minor that is submitted
more than one year after the date FDA issued the CRL will be reclassified as a Major
Amendment, except for ANDAs for products that are on the drug shortage list under
section 506E of the FD&C Act (21 U.S.C. 356e), or are the subject of a response to a
Public Health Emergency as declared by the Secretary of the U.S. Department of
Health and Human Services under section 319 of the Public Health Service Act (PHS
Act) (42 U.S.C. 247d), or are anticipated to be subject to the same criteria as apply to
such a declaration, at the time of submission.
7. Reclassification of Facility-Based Major CRL Amendments
a. Upon submission of a Facility-Based Major CRL Amendment, an applicant can
request that FDA reclassify the Major Amendment to minor.
b. A request for reclassification must be made at the time of amendment submission
and include supporting information detailing why the facility deficiency has been
resolved and no additional facility assessment is needed.
c. FDA will grant the request to reclassify the Facility-Based Major CRL
Amendment if FDA determines that none of the following are necessary to
complete the assessment of the amendment:
i. A facility inspection
ii. Use of alternate tools for facility assessment
iii. Continued assessment of inspection deficiency responses
d. If FDA denies the request, the Agency will communicate the substantive basis of
the denial to the applicant and the ANDA amendment will be assigned a 6-, 8- or
10-month goal date, as applicable, from the original date of the amendment
submission.
e. FDA will make a decision on a request for reclassification of a Facility-Based
Major CRL Amendment within 30 days from the date of submission for priority
amendments, and within 60 days from the date of submission for standard
amendments. If the Facility-Based Major CRL Amendment is reclassified as
minor, the goal date will be 3 months from the end of the 30- or 60-day decisional
period, as applicable.

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f. The goal dates for decisions on requests for reclassification and amendment
assessment for which a request for reclassification is submitted are as follows:

Submission
Type

Standard
Major
Amendment

Priority
Major
Amendment

FDA Response
Regarding Major
to Minor
Reclassification
Within 60 days of
submission date

New ANDA Goal
Date if
Reclassification
Granted
Within 5 months of
submission date

Within 30 days of
submission date

Within 4 months of
submission date

ANDA Goal Date if
Reclassification Denied

Within 8 months of
submission date if
preapproval inspection is not
required
Within 10 months of
submission date if
preapproval inspection is
required
Within 6 months of
submission date if
preapproval inspection is not
required
Within 8 months of
submission date if
preapproval inspection
required and applicant meets
the requirements under
section I(A)(5)(b)
Within 10 months of
submission date if
preapproval inspection
required and applicant meets
any limitations as described
under section I(A)(6)

D. ANDA Approval and Tentative Approval
If applicants submit and maintain ANDAs consistent with the statutory requirements for
approval under 505(j) of the FD&C Act; respond to IRs and DRLs completely and within
the time frames requested by FDA; and timely submit all required information under 21
CFR parts 314 and 210, including information concerning notice (21 CFR 314.95),
litigation status (21 CFR 314.107), and commercial marketing (21 CFR 314.107); then
FDA will strive to:
1. Approve approvable ANDAs in the first assessment cycle;
2. Approve First Generics on the earliest lawful approval date, if known to FDA; and
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3. Tentatively approve or approve ANDAs for “First Applicants” as described in section
505(j)(5)(B)(iv)(II)(bb) of the FD&C Act to avoid forfeiture of 180-day exclusivity.
E. Dispute Resolution
1. An applicant may pursue a request for reconsideration within the assessment
discipline at the Division level or original signatory authority, as needed.
2. The Office of Generic Drugs, Office of Regulatory Operations Associate Director
will track each request for Division-level reconsideration through resolution.
3. Following resolution of a request for reconsideration, an applicant may pursue formal
dispute resolution above the Division level, pursuant to procedures set forth in
Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for
Industry and Review Staff (May 2019).
4. FDA will respond to 90 percent of appeals above the Division level within 30 days of
CDER’s receipt of the written appeal.
5. CDER’s Formal Dispute Resolution Project Manager (or designee) will track each
formal appeal above the Division level through resolution.
F. Pre-Submission Facility Correspondence
1. For the purposes of section I.A. and I.B. above, FDA will consider a PFC to be
complete and accurate if the submission consists of the following:
a. For each manufacturing and testing facility involved in manufacturing processes
and testing for the ANDA and corresponding Type II API DMF:
i. facility name, operation(s) performed, facility contact name, address, FDA
Establishment Identifier (FEI) number (if a required registrant or one has been
assigned), DUNS number, registration information (for required registrants),
and a confirmation that the facility is ready for inspection,
ii. information needed to inform FDA’s decision regarding the need for a
preapproval inspection, such as a description of the manufacturing process
and controls of critical steps, identification of any anticipated differences
between pilot/exhibit scale and commercial scale processes, and as otherwise
described in the guidance for industry on ANDAs: Pre-Submission of Facility
Information Related to Prioritized Generic Drug Applications (PreSubmission Facility Correspondence) (November 2017) and any revisions,
and

19

iii. a certification by the applicant that any Type II DMF has similarly complete
and accurate facility information, including complete facility information (i.e.,
facility name, operation, facility contact name, address, FEI number and
DUNS number, and a confirmation that the facility is ready for inspection).
b. Information needed to inform FDA’s decision regarding the need for a
preapproval inspection, such as a description of the drug substance manufacturing
process, that is included in a corresponding Type II DMF is not required to be
duplicated in the PFC for the ANDA if it is included in a corresponding Type II
DMF.
c. For all sites or organizations involved in all bioequivalence and clinical studies
used to support the ANDA submission: site names, addresses, and website; the
study numbers; a list and description of all study investigators consistent with the
guidance ICH E3 Structure and Content of Clinical Study Reports (July 1996)
section 16.1.4; the study conduct dates; and study protocols and any available
amendments.
d. For all sites or organizations involved in analytical studies used to support the
ANDA application submission the following are required: analytical site name,
address, and website. For those studies that were initiated no later than 60 days
prior to the ANDA submission, additional requirements are:
i. a list of investigator name(s)
ii. study conduct dates; and
iii. if the analytical method validation was completed before dosing, the
analytical method validation study report(s).
e. This information is provided using a standardized electronic format and includes
unique identifiers that are current and accurate.
2. Changes to information contained in a PFC when submitted in an ANDA that are
considered a “significant change” include changes in the identified facilities for
manufacture of the drug substance or drug product, the proposed manufacturing
operations or operating principles, and the order of manufacturing unit operations, as
described in the guidance ANDAs: Pre-Submission of Facility Information Related to
Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence)
(November 2017) and any revisions.

20

G. Other ANDA Assessment Program Aspirations
1. FDA aspires to continually improve the efficiency of the ANDA Assessment
program.
2. The absence of a GDUFA III commitment for a specific program function does not
imply that the program function is not important. For example, other program
functions include determining whether listed drugs were voluntarily withdrawn from
sale for reasons of safety or effectiveness and ANDA proprietary name evaluations.
III. PRE-ANDA PROGRAM
A. Goal of Pre-ANDA Program
1. The goal of the pre-ANDA program is to clarify regulatory expectations for
prospective applicants early in product development, assist applicants in developing
more complete submissions, promote a more efficient and effective ANDA
assessment process, and reduce the number of assessment cycles required to obtain
ANDA approval.
2. Some elements of these programs are tailored to enhance the development of
Complex Generic Products. Complex Generic Products can raise unique scientific
and regulatory considerations, and FDA is committed to providing further
transparency and clarity on Complex Generic Product development and assessment to
help increase the availability of these products.
B. Suitability Petitions
1. In FY 2023, FDA will work diligently to enhance the Agency’s processes for
reviewing and responding to petitions submitted under section 505(j)(2)(C) of the
FD&C Act (commonly referred to as “suitability petitions”), and to review and
respond to pending suitability petitions.
2. Prior to FY 2024, FDA will take appropriate action to determine if petitioners who
submitted suitability petitions prior to FY 2023 remain interested in a response.
3. FDA will conduct a completeness assessment for suitability petitions submitted in
FY 2024-2027. The timeframe for the completeness assessment will be:
a. 21 days after the date of petition submission; or
b. If an IR is issued as part of the completeness assessment and the petitioner
submits a response, FDA will finish the completeness assessment within 21
days after the date of receipt of the IR response.

21

4. Any suitability petition submitted in FY 2024-2027 will receive a goal date described
in section III(B)(7). Any suitability petitions submitted to FDA prior to FY 2024 will
not receive a goal date. If a petitioner wants to receive a goal date on a suitability
petition submitted prior to FY 2024, the petitioner may withdraw and submit a new
suitability petition in FY 2024-2027.
5. The date of submission for the purposes of determining the fiscal year of submission
will be the date of FDA’s completion of the completeness assessment.
6. FDA will prioritize the review of suitability petitions for a drug product that:
a. could mitigate or resolve a drug shortage and prevent future shortages;
b. address a public health emergency declared by the Secretary of the U.S.
Department of Health and Human Services under section 319 of the PHS Act,
or anticipated under the same criteria as apply to such a declaration;
c. is for a new strength of a parenteral product that could aid in eliminating
pharmaceutical waste or mitigating the number of vials needed per dose by
addressing differences in patient weight, body size, or age; or
d. is subject to special review programs under the President’s Emergency Plan for
AIDS Relief (PEPFAR).
7. Beginning in FY 2024, FDA will review and respond to suitability petitions that have
been assigned a goal date pursuant to the following goals:
a. In FY 2024, 50 percent of submissions within 6 months after completeness
assessment, up to a maximum of 50 suitability petitions completed;
b. In FY 2025, 70 percent of submissions within 6 months after completeness
assessment, up to a maximum of 70 suitability petitions completed;
c. In FY 2026, 80 percent of submissions within 6 months after completeness
assessment, up to a maximum of 80 suitability petitions completed; and
d. In FY 2027, 90 percent of submissions within 6 months after completeness
assessment, up to a maximum of 90 suitability petitions completed.
8. As a general matter, if FDA misses goal dates on suitability petitions due to increased
submissions, FDA will prioritize the review of suitability petitions for which a goal
date was missed prior to reviewing newly submitted suitability petitions for the
current fiscal year, except for those suitability petitions that are prioritized under
section III(B)(6). See Appendix for additional information on FDA’s review of
suitability petitions in GDUFA III.

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C. Product-Specific Guidance
1. FDA will continue to issue PSG identifying the methodology for generating evidence
needed to support ANDA approval.
2. FDA will issue PSGs consistent with the following goals:
a. For Complex Products approved in new drug applications (NDAs) on or after
October 1, 2022, a PSG will be issued for 50 percent of such NDA products
within 2 years after the date of approval, and for 75 percent of such NDA
products within 3 years after the date of approval.
b. FDA will continue to develop PSGs for Complex Products approved prior to
October 1, 2022, for which no PSG has been published.
c. For non-complex drug products approved in NDAs on or after October 1, 2022,
that contain a new chemical entity (NCE) (as described in section 505(j)(5)(F)(ii)
of the FD&C Act), a PSG will be issued within 2 years after the date of approval
for 90 percent of such products.
3. Information on PSG Development:
a. FDA will provide on its website information related to upcoming new and revised
PSGs to support the development and approval of safe and effective generic drug
products, including the projected date of PSG publication, which may be subject
to change. When FDA becomes aware that it will not meet the issuance date
listed on the website, FDA will update the website to provide a new projected
issuance date in the next scheduled update.
b. FDA routinely will update the information on this website approximately every 4
months.
c. PSGs will be developed (or revised) and issued in accordance with FDA’s Good
Guidance Practices and will be reviewed by senior management and other
designated subject matter experts prior to publication and after consideration of
any public comments submitted to the relevant docket of a published draft or final
PSG.
4. Prioritization of PSG Development:
a. FDA will make available on its website information on how the Agency
prioritizes the development of PSGs.

23

b. Industry may request via the portal for Controlled Correspondence that FDA
develop a PSG. FDA will consider this request in prioritizing PSG development
but will not consider this to be a Controlled Correspondence.
c. FDA will seek public input on prioritization of PSGs annually during the public
meeting on research prioritization described in section V(B)(2).
d. For Complex Products, FDA generally will prioritize the development of PSGs
for Complex Products that contain a NCE (as described in section 505(j)(5)(F)(ii)
of the FD&C Act) over Complex Products that do not contain an NCE.
5. When a new or revised PSG is published and an applicant or prospective applicant
has already commenced an in vivo bioequivalence study (i.e., the study protocol has
been signed by the study sponsor and/or the contract research organization) the
applicant or prospective applicant may request a PSG Teleconference to obtain
Agency feedback on the potential impact of the new or revised PSG on its
development program.
a. To be eligible for a PSG Teleconference, the applicant or prospective applicant
must submit with the meeting request the signature page of the relevant in vivo
study protocol signed by the study sponsor and/or the contract research
organization.
b. FDA will hold a PSG Teleconference within 30 days after the receipt of the
meeting request. The PSG Teleconference will be scheduled for 60 minutes.
c. If the applicant seeks further feedback from FDA after a PSG Teleconference, the
applicant may utilize the Controlled Correspondence process or request an
additional meeting. The purpose of this meeting is to provide a forum in which
industry can discuss the scientific rationale for an approach other than the
approach recommended in the PSG to ensure that the approach complies with the
relevant statutes and regulations.
i. If the applicant has not submitted an ANDA, the prospective applicant can
submit a request for a Pre-Submission PSG Meeting. FDA will grant or deny
the meeting within 14 days after receipt of the request and if granted, will
schedule the meeting within 120 days after receipt of the request.
ii. If the applicant has submitted an ANDA, the applicant can submit a request
for a Post-Submission PSG Meeting. FDA will grant or deny the meeting
within 14 days after receipt of the request, and if granted, will schedule the
meeting within 90 days after receipt of the request.

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iii. FDA may deny a Pre- or Post-Submission PSG Meeting if the request is
incomplete, or the inquiry would be more appropriately resolved through a
Controlled Correspondence. FDA may grant a Pre- or Post-Submission
Meeting request after such a Controlled Correspondence if the Agency
determines that any issue(s) remain unresolved or would be more
appropriately resolved in a meeting.
iv. Applicants and prospective applicants are eligible to request a Pre-Submission
PSG Meeting or Post-Submission PSG Meeting regardless of whether they
have had a Product Development Meeting or a post-CRL Scientific Meeting.
6. When FDA intends to issue a new or revised PSG and there are ANDAs under review
that may be impacted by changes to the new or revised PSG, FDA will ensure that at
least division-level program leadership is aware of the potential impact on the
pending ANDAs for drug products with related new or revised PSGs.
D. Product Development Meetings
1. A prospective applicant can request a pre-ANDA submission Product Development
Meeting. The purpose of the meeting is to provide a forum for a scientific exchange
on specific issues (e.g., a proposed study design, alternative approach, additional
study expectations, or questions) in which FDA will provide targeted advice
regarding an ongoing ANDA development program.
2. FDA will grant a prospective applicant a Product Development Meeting if, in FDA’s
judgment:
a. The requested Product Development Meeting concerns:
i. Development of a Complex Generic Product for which FDA has not issued a
PSG; or
ii. An alternative equivalence evaluation, i.e., change in study type, such as in
vitro to clinical, for a Complex Generic Product for which FDA has issued a
PSG;
b. The prospective applicant submits a complete meeting package, including a data
package and specific proposals;
c. A Controlled Correspondence response would not adequately address the
prospective applicant’s questions; and
d. A Product Development Meeting would significantly improve ANDA assessment
efficiency.

25

3. Dependent on available resources, FDA may grant a prospective applicant a Product
Development Meeting concerning development issues other than those described in
Section III(D)(2) if, in FDA’s judgment:
a. The prospective applicant submits a complete meeting package, including a data
package and specific proposals;
b. A Controlled Correspondence response would not adequately address the
prospective applicant’s questions; and
c. A Product Development Meeting would significantly improve ANDA assessment
efficiency.
4. FDA will grant or deny 90 percent of Product Development Meeting requests within
14 days after receipt of the meeting request.
5. FDA will conduct 90 percent of Product Development Meetings within 120 days after
the meeting is granted.
6. FDA can meet the Product Development Meeting goal by either conducting a meeting
or providing a meaningful written response that will inform drug development and/or
regulatory decision-making to the prospective applicant, within the applicable goal
date.
7. Unless FDA is providing a written response to satisfy the Product Development
Meeting goal, FDA will provide preliminary written comments before each Product
Development Meeting (and aspire to provide the written comments 5 days before the
meeting) and will provide meeting minutes within 30 days following the meeting.
E. Pre-Submission Meetings
1. Prospective applicants may request a Pre-Submission Meeting. The purpose of a PreSubmission Meeting is to provide an applicant the opportunity to present unique or
novel data or information that will be included in the ANDA submission such as
formulation, key studies, justifications, and/or methods used in product development,
as well as the interrelationship of the data and information in the ANDA. FDA will
grant a Pre-Submission Meeting, if the applicant was granted a Product Development
Meeting for the same Complex Generic Product or FDA believes in its sole discretion
that the Pre-Submission Meeting would improve assessment efficiency.
2. For Pre-Submission Meetings, FDA will:
a. Identify the ANDA assessment team members who will attend the meeting;

26

b. Identify additional content for the meeting in the letter granting the meeting
request, including information on what topics should be addressed in the meeting
in addition to those identified in the meeting request by the applicant; and
c. Identify at the meeting, items or information for clarification before the
applicant’s submission of the ANDA.
3. FDA will not provide a substantive assessment of summary data or full study reports
at the meeting.
4. An applicant’s decision not to request a Pre-Submission Meeting will not prejudice
the receipt or assessment of an ANDA.
5. FDA will grant or deny 90 percent of Pre-Submission Meeting requests within 30
days.
6. If granted, FDA will conduct 90 percent of Pre-Submission Meetings within 60 days
of the meeting request.
7. FDA will provide preliminary written comments 5 days before each meeting, and
meeting minutes within 30 days after the meeting.
IV. ANDA Assessment Meeting Program
A. Goal of the ANDA Assessment Meeting Program
1. The goal of the ANDA Assessment Meeting Program is to provide or continue to
provide targeted, robust advice to ANDA applicants as they work to meet the
standards for ANDA approval.
2. Some elements of this program are tailored to enhance the development of Complex
Generic Products.
B. Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings
1. If an applicant for a Complex Generic Product was granted a Product Development
Meeting for the same product, they may, within 7 days of receiving the last midCycle DRL, submits a request for a Mid-Cycle Review Meeting or an Enhanced MidCycle Meeting. The request should describe the specific deficiency(ies) to be
discussed.
2. Mid-Cycle Review Meetings:
a. The purpose of a Mid-Cycle Review Meeting is for the applicant to ask for the
rationale for any deficiency identified in the mid-cycle DRL(s), and/or to ask

27

questions related to FDA’s assessment of the data or information in the ANDA.
An applicant may not present any new data or information at this meeting.
b. The Mid-Cycle Review Meeting will take place within 30 days after the date the
sponsor submits a meeting request.
3. Enhanced Mid-Cycle Review Meetings:
a. The purpose of this meeting is for the applicant to ask questions related to a
proposed scientific path to address possible deficiencies identified in the midcycle DRL(s). An applicant may ask questions about potential new data or
information to address any possible deficiencies identified in the mid-cycle
DRL(s). FDA will discuss the data and information but will not provide
substantive assessment of data or information provided by the applicant at the
meeting.
b. If an Enhanced Mid-Cycle Review Meeting is requested, the meeting will take
place within 90 days after issuance of the last mid-cycle DRL.
c. FDA will extend the ANDA goal date by 60 days if an applicant requests an
Enhanced Mid-Cycle Review Meeting. FDA also will extend the response due
date for the relevant DRL(s) by recalculating the response due date starting from
the date of the meeting, e.g., if the response was due 30 days after the DRL was
issued, it will now be due 30 days after the Enhanced Mid-Cycle Review
Meeting.
d. An applicant may submit an Unsolicited Amendment after an Enhanced MidCycle Review Meeting, which could result in an additional goal date extension
consistent with section I(C).
C. Post-CRL Scientific Meetings
1. An applicant can request a Post-CRL Scientific Meeting. The purpose of this meeting
is to provide an applicant scientific advice on possible approaches to address
deficiencies identified in a CRL related to establishing equivalence.
a. An applicant’s meeting request must discuss:
iii. a new equivalence study needed to address the deficiencies in the design
identified in the CRL,
iv. an approach that is different from that submitted in the ANDA, e.g., a change
in study type from in vivo to in vitro,

28

v. a new comparative use human factors study, or
vi. a new approach to demonstrating sameness of a complex active ingredient;
and
b. FDA will grant the meeting if it is for a Complex Generic Product or in FDA’s
judgment the request raises issues that are best addressed via this meeting process
and cannot be adequately addressed through Controlled Correspondence.
c. An applicant may have a post-CRL teleconference described in section II(B)(8)(a)
prior to requesting this meeting.
2. FDA will grant or deny the Post-CRL Scientific Meeting request within 14 days after
receipt of the request.
3. FDA will hold the Post-CRL Scientific Meeting within 90 days after the date the
meeting is granted.
4. Applicants are eligible to request a Post-CRL Scientific Meeting even if they have not
had a Product Development Meeting.
V. ADDITIONAL PROGRAM ENHANCEMENTS AND ASPIRATIONS
A. Inactive Ingredient Database Enhancement
FDA will update the Inactive Ingredient Database on an ongoing basis, and post quarterly
notices of updates made. Such notices will include for each change made during the
previous quarter, the new information, and the information that was replaced.
B. Regulatory Science Enhancements
1. FDA will conduct internal and external research to support fulfilment of submission
assessment and pre-ANDA commitments set forth in Sections I and III, respectively.
2. Annually, FDA will conduct a public workshop to solicit input from industry and
stakeholders for inclusion in an annual list of GDUFA III regulatory science
initiatives. Interested parties may propose regulatory science initiatives via email to
[email protected]. After considering Industry and stakeholder input, FDA
will post the list on FDA’s website.
3. If Industry forms a GDUFA III regulatory science working group, then upon request
of the working group to the Director of the Office of Research and Standards in the
Office of Generic Drugs, FDA will meet with the working group twice yearly to
discuss current and emerging challenges and concerns. FDA will post minutes of

29

these meetings on its website.
4. Annually, FDA will report on its website the extent to which GDUFA regulatory
science-funded projects support the development of generic drug products, the
generation of evidence needed to support efficient assessment and timely approval of
ANDAs, and the establishment of new approaches to evaluate generic drug
equivalence.
C. Other Pre-ANDA and Assessment Meeting Program Aspirations
FDA aspires to continually improve the effectiveness of its Pre-ANDA and ANDA
Assessment Meeting activities.
VI. DMF ASSESSMENT PROGRAM ENHANCEMENTS
A. Communication of DMF Assessment Comments
1. FDA will ensure that DMF assessment comments submitted to the DMF holder are
issued at least in parallel with the issuance of review comments relating to the DMF
for the ANDA.
2. This commitment applies to comments to the applicant issued in any ANDA CRL and
comments issued in the first IR letter by the drug product assessment discipline.
B. Teleconferences to Clarify DMF First Cycle Assessment Deficiencies
1. FDA will grant and conduct teleconferences when requested to clarify deficiencies in
first cycle DMF deficiency letters.
2. DMF holders must request such teleconferences in writing within 30 days of issuance
of the first cycle DMF deficiency letter, identifying specific issues to be addressed.
FDA may initially provide a written response to the request for clarification, but if the
DMF holder indicates that a teleconference is still desired, FDA will schedule the
teleconference.
3. FDA will strive to grant such teleconferences within 30 days of receipt of the initial
teleconference request, giving priority to DMFs based on the priority of the
referencing ANDA.
4. In lieu of a teleconference, the DMF holder may submit a request for an email
exchange between FDA and the DMF holder. The request must identify specific

30

issues to be addressed. After FDA responds to the request, the DMF holder may
submit, and FDA will respond to, one follow-up email to obtain additional
clarification.
C. DMF First Adequate Letters
Once a DMF has undergone a full scientific assessment and has no open issues related to
the assessment of the referencing ANDA, FDA will issue a First Adequate Letter.
D. DMF No Further Comment Letters
Once a DMF has undergone a full scientific assessment and the ANDA referencing the
DMF has been approved or tentatively approved, FDA will issue a “no further comment”
letter.
E. DMF Review Prior to ANDA Submission
1. A holder of a DMF may submit a request for assessment of the DMF six months prior
to the planned submission date for: 1) an original ANDA, 2) an ANDA amendment
containing a response to a CRL, or 3) an amendment seeking approval of an ANDA
that previously received a tentative approval. In each case, the submission must
include reference to a DMF for which FDA has not conducted a substantive
assessment, and one of the following criteria must be met:
a. All patents and exclusivities will expire within 12 months of the planned
submission date;
b. The submission is for a drug product for which there are not more than three
approved drug products listed in FDA’s Approved Drug Products With
Therapeutic Equivalence Evaluations (the “Orange Book”), for which there are no
blocking patents or exclusivities listed for the RLD, and the ANDA applicant is
not seeking approval for less than all of the conditions of use on the RLD
labeling, e.g., a “carve-out.” In other words, there are fewer than four approved
therapeutically equivalent drug products, including the RLD, listed in the Orange
Book, no blocking patents or unexpired exclusivities for the RLD in the Orange
Book, and the applicant is not seeking to “carve out” any conditions of use;
c. The submission is for a drug product that could help mitigate or resolve a drug
shortage and prevent future shortages, including submissions related to products
that are listed on FDA’s Drug Shortage List at the time of the submission;

31

d. The submission is for a drug product that either could help address a public health
emergency declared by the Secretary of the U.S. Department of Health and
Human Services under section 319 of the PHS Act, or anticipated under the same
criteria as apply to such a declaration; or
e. The submission is for a drug product for which (1) there is only one approved
drug product listed in the Prescription Drug Product List (i.e., the “Active
Section”) of the Orange Book and that product is approved under an ANDA (i.e.,
the RLD is in the ”Discontinued Section” and there is not more than one ANDA
in the “Active Section”); (2) the approved ANDA for the drug product listed in
the “Active Section” was not approved pursuant to a suitability petition under
section 505(j)(2)(C) of the FD&C Act; (3) there are no blocking patents or
exclusivities for the RLD; and (4) the submission does not qualify for
prioritization under any other factor listed in MAPP 5240.3 Rev. 5: Prioritization
of the Review of Original ANDAs, Amendments, and Supplements.
2. A holder of a DMF may submit a request for assessment of the DMF six months prior
to the planned submission date for a PAS to add a new API source, provided that:
a. The PAS is for a drug product that could help mitigate or resolve a drug shortage
and prevent future shortages, including submissions related to products that are
listed on FDA’s Drug Shortage List at the time of the submission; or
b. The PAS is for a drug product that either could help address a public health
emergency declared by the Secretary of the U.S. Department of Health and
Human Services under section 319 of the PHS Act, or anticipated under the same
criteria as apply to such a declaration.
3. To be eligible for this review, a DMF holder must submit with its request for review:
a. at least one Letter of Authorization with one pre-assigned ANDA number;
b. a reference to the corresponding RLD listed in the Orange Book; and
c. documentation that the DMF holder has paid a GDUFA DMF fee as described in
section 744B(a)(2)(A) of the FD&C Act (21 U.S.C. 379j-41(a)(2)(A)) for the
current fiscal year.

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F. FDA Assessment of Solicited DMF Amendments
1. FDA will assess solicited DMF amendments related to original ANDAs and PASs
upon receipt even if the original ANDA or PAS in which the DMF is referenced is
not currently under assessment.
2. Such assessments will be conducted based on the assessment status of the DMF and
other disciplines in the related ANDAs, with priority being given to those
amendments related to ANDAs for which acceptability of the DMF assessment may
result in an approval.
G. FDA Communication Related to DMF Amendments and ANDAs
FDA will communicate publicly to industry that prior to submitting a DMF amendment,
the DMF holder should coordinate with the ANDA applicant that references the DMF to
avoid delaying approval or tentative approval of the ANDA.
VII.

FACILITIES

A. Foreign Regulators
1. Export Support and Education of Other Health Authorities: FDA will support the
export of safe and effective pharmaceutical products by the U.S.-based
pharmaceutical industry, including but not limited to providing timely updates to
FDA’s Inspection Classification Database as described below, and educating other
health authorities regarding FDA’s surveillance inspection program and the meaning
of inspection classifications.
2. Communications to Foreign Regulators: Upon receipt of a written or email request by
an establishment physically located in the U.S. that has been included as part of a
marketing application submitted to a foreign regulator, issue within 30 days of the
date of receipt of the request a written communication to that foreign regulator
conveying the current compliance status for the establishment.
B. Communication Regarding Inspections
1. When FDA conducts a preapproval inspection of a facility or site named in the
ANDA, PAS, or associated Type II DMF and identifies outstanding issues that could
prevent approval of an ANDA or PAS, the applicant will be notified that issues exist
through an IR, DRL or CRL pursuant to Section II(B) above.
2. FDA agrees to communicate to the facility owner final inspection classifications that
do not negatively impact approvability of any pending application within 90 days of
the end of the inspection.
33

3. FDA agrees to ongoing periodic engagement with industry stakeholders to provide
updates on Agency activities and seek stakeholder feedback.
C. GDUFA III Inspection Classification Database
The Inspection Classification Database will be updated every 30 days and will reflect
FDA’s final assessment of the facility or site following an FDA inspection and
assessment of the inspected entity’s timely response to any documented observations.
FDA will update the existing publicly available Inspection Classification Database
webpage and will develop communication materials to provide further information to
industry and foreign regulators on how FDA determines which facilities to select for a
drug surveillance inspection, including how FDA uses its risk-based site selection model
to determine the frequency of surveillance inspections.
D. Post-Warning Letter Meetings
1. An eligible facility described in section VII(D)(3) may request a meeting with FDA
regarding the facility’s remediation for deviations identified in a warning letter (PostWarning Letter Meeting).
a. This meeting generally will take place 6 months or later after the facility submits
an initial response to an FDA warning letter.
b. A facility may request that the meeting take place prior to 6 months after an initial
response to a warning letter has been submitted. However, it is at FDA’s
discretion to grant an earlier meeting if the Agency determines it would be
beneficial to both parties.
2. The purpose of the Post-Warning Letter Meeting is to obtain preliminary feedback
from FDA on the adequacy and completeness of the facility’s corrective action plans.
3. To be eligible for the Post-Warning Letter Meeting:
a. The facility Current Good Manufacturing Practice (CGMP) compliance status is
“Official Action Indicated” as a result of an FDA inspection;
b. The facility has paid a GDUFA facility fee as described in section 744B(a)(4) of
the FD&C Act for the current fiscal year, or is named in a pending ANDA
application; and

34

c. The regulatory action (e.g., warning letter) is limited only to violations or
deviations from Section 501 of the FD&C Act (21 U.S.C. 351) related to human
drug manufacturing, including manufacturing of a drug-device combination
product.
4. The meeting request will be granted only if the facility has submitted to FDA a
thorough and complete corrective action and preventive action (CAPA) plan that
addresses all items cited in the warning letter, and reasonable progress has been made
toward remediation.
5. Any supplemental information submitted by a facility on remediation progress to be
discussed at the meeting must be submitted at least 60 days prior to the meeting.
6. FDA may deny a request for a Post-Warning Letter Meeting if FDA determines that a
facility is ineligible for a meeting or does not appear to be ready for a meeting as
evidenced by an incomplete CAPA plan, and/or insufficient progress being made to
remediate the facility issues. If FDA denies the meeting:
a. In general, FDA intends to respond briefly with comments regarding why the
meeting package is not sufficiently developed or complete (e.g., where the facility
has not presented a proposed CAPA plan for all items in the warning letter or
where the firm does not appear to have made reasonable efforts to implement its
proposed CAPA plan).
b. A facility may resubmit a new meeting request no sooner than 3 months after the
first meeting request is denied by FDA.
7. Only two Post-Warning Letter Meeting requests per warning letter may be made
under this section.
8. FDA may defer a Post-Warning Letter Meeting if FDA has made a decision that a reinspection is the most appropriate next step (i.e., defer in favor of re-inspection). In
this case, FDA will notify the facility of the decision to re-inspect rather than grant a
meeting.
9. FDA may schedule meetings by video conference, teleconference, or face-to-face, at
FDA’s discretion.

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10. The following goals apply to FDA’s decision to grant, deny, or defer in favor of reinspection a Post-Warning Letter Meeting:
a. In FY 2024, 50 percent of eligible requests within 30 days of request.
b. In FY 2025, 70 percent of eligible requests within 30 days of request.
c. In FY 2026 and FY 2027, 80 percent of eligible requests within 30 days of
request.
11. The commitment to hold a Post-Warning Letter Meeting:
a. Does not preclude FDA from taking any regulatory actions necessary, including a
follow-up inspection at any time (including prior to the Post-Warning Letter
Meeting); and
b. As with other regulatory meetings, FDA advice is not binding on the Agency.
12. Guidance related to Post-Warning Letter Meeting process set forth in this section
VII(D):
a. FDA will issue guidance regarding the Post-Warning Letter Meeting process,
including recommendations on items facilities should submit as part of a meeting
request.
b. If more than 50 percent of first-time meeting requests are denied because FDA
makes an assessment that the facility is not ready, FDA agrees to take appropriate
action to provide additional information on meeting requests, which could include
updating the guidance described in VII(D)(12)(a) to provide further information
on how facilities can avoid issues that have commonly led to meeting requests
being denied.
E. Generic Drug Manufacturing Facility Re-inspection
1. An eligible facility as described in section VII(E)(2) may request a re-inspection.
2. To be eligible for the facility re-inspection process reflected in this section:
a. The facility CGMP compliance status is “Official Action Indicated” as a result of
an FDA inspection;
b. The facility has paid a GDUFA facility fee as described in section 744B(a)(4) of
the FD&C Act for the current fiscal year, or is named in a pending ANDA
application; and
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c. The regulatory action (e.g., warning letter) is limited only to violations or
deviations from Section 501 of the FD&C Act related to human drug
manufacturing, including manufacturing of a drug-device combination product.
3. FDA will review the request and if FDA determines that the requesting facility has
appropriately completed CAPAs that sufficiently address all of the deficiencies in a
warning letter, with the exception of ongoing monitoring, and FDA agrees that the
facility appears ready for inspection, FDA will generate an inspectional assignment.
4. FDA agrees to notify the facility of the Agency’s decision to re-inspect within 30
days of receipt of the request for re-inspection.
5. If FDA declines the request to reinspect:
a. FDA agrees to notify the facility of its decision and provide a brief high-level
explanation, for example, that the firm has not made sufficient progress to
complete certain CAPAs identified as necessary to resolve a violation cited in the
warning letter.
b. The facility may submit a second request for a re-inspection no earlier than 3
months after receiving FDA’s initial decision.
c. If the second request is denied, facility will be considered to no longer meet the
eligibility criteria in section VII(E)(2).
6. The processes and timelines set forth in this section apply only to the first reinspection after a warning letter. If the warning letter is not resolved after reinspection, the facility will be considered to no longer meet the eligibility criteria in
section VII(E)(2).
7. If a re-inspection request is granted, FDA agrees to notify the facility and issue an
inspectional assignment in conjunction with the notification. The applicable goals for
domestic facilities are:
a. In FY 2024, for 60 percent of the requests for reinspection that are granted, FDA
will re-inspect the facility within 4 months of the letter to the facility indicating
FDA’s intent to reinspect.
b. In FY 2025, for 70 percent of the requests for reinspection that are granted, FDA
will re-inspect the facility within 4 months of the letter to the facility indicating
FDA’s intent to reinspect.

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c. In FY 2026 and FY 2027, for 80 percent of the requests for reinspection that are
granted, FDA will re-inspect the facility within 4 months of the letter to the
facility indicating FDA’s intent to reinspect.
8. The applicable goals for international facilities are:
a. In FY 2024, for 60 percent of the requests for reinspection that are granted, FDA
will re-inspect the facility within 8 months of the letter to the facility indicating
FDA’s intent to re-inspect.
b. In FY 2025, for 70 percent of requests for reinspection that are granted, FDA will
re-inspect the facility within 8 months of the letter to the facility indicating FDA’s
intent to re-inspect.
c. In FY 2026 and FY 2027, for 80 percent of requests for reinspection that are
granted, FDA will re-inspect the facility within 8 months of the letter to the
facility indicating FDA’s intent to re-inspect.
VIII.

CONTINUED ENHANCEMENT OF USER FEE RESOURCE MANAGEMENT

A. Sustainability of GDUFA Program Resources
1. FDA is committed to ensuring the sustainability of the GDUFA program resources
and to enhancing the operational agility of the GDUFA program.
2. FDA will build on the financial enhancements included in GDUFA II and continue
activities in GDUFA III to ensure optimal use of user fee resources and the alignment
of staff to workload through the continued maturation and assessment of the
Agency’s resource capacity planning capability.
3. FDA also will continue activities to promote transparency of the use of financial
resources in support of the GDUFA program.
B. Resource Capacity Planning
1. FDA will continue activities to mature the Agency’s resource capacity planning
function, including utilization of modernized time reporting to support enhanced
management of GDUFA resources in GDUFA III and implementation of the Capacity
Planning Adjustment (CPA).
2. Resource Capacity Planning Implementation
a. By the end of the second quarter of FY 2023, FDA will publish an
implementation plan that will describe how resource capacity planning and time
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reporting will continue to be utilized during GDUFA III. This implementation
plan will address topics relevant to the maturation of resource capacity planning
including, but not limited to, detailing FDA’s approach to:
i. The continued maturation of the Agency’s resource capacity planning
capability;
ii. The continual improvement of time reporting and its utilization in the CPA;
iii. The integration of resource capacity planning analyses in the Agency’s
resource and operational decision-making processes; and
iv. The implementation of the CPA, with a first year of adjustment for FY 2024
user fees.
b. FDA will provide annual updates on the FDA website on the Agency’s progress
relative to activities detailed in this implementation plan by the end of the
second quarter of each subsequent fiscal year.
c. FDA will document in the annual GDUFA Financial Report how any CPA fee
revenues are being utilized.
d. Resources obtained from the CPA shall be used, consistent with user fee
appropriations, to support CDER or ORA staff engaged in GDUFA program
work, or other non-CDER staff who are directly supporting GDUFA review
work.
e.

The CPA shall be limited to workload driven by:
i. ANDA Originals and Resubmissions/Amendments
ii. ANDA Supplements (PAS and “Changes Being Effected” (CBE)
supplements) and Amendments
iii. Controlled Correspondence as defined in Section XI(I)-(J)
iv. Pre-ANDA Meetings, which include Pre-Submission, Product Development,
and Pre-Submission PSG Meetings
v. Surveillance inspections

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vi. Post-marketing safety activities
vii. Suitability Petitions
C. Resource Capacity Planning Assessment
1. By the end of FY 2025, an independent contractor will complete and publish an
evaluation of the resource capacity planning capability. This will include an
assessment of the following topics:
a. The ability of the CPA to forecast resource needs for the GDUFA program,
including an assessment of the scope of the workload drivers in the CPA and their
ability to represent the overall workload of the GDUFA program;
b. Opportunities for the enhancement of time reporting toward informing resource
needs; and
c. The integration and utilization of resource capacity planning information within
resource and operational decision-making processes of the GDUFA program.
2. The contractor will provide options and recommendations in the evaluation regarding
the continued enhancement of the above topics as warranted. The evaluation findings
and any related recommendations will be discussed at the FY 2026 GDUFA 5-year
financial plan public meeting. The findings and recommendations of the evaluation
may inform the CPA methodology for future reauthorizations.
D. Financial Transparency and Efficiency
1. FDA is committed to ensuring GDUFA user fee resources are administered,
allocated, and reported in an efficient and transparent manner. FDA will conduct
activities to evaluate the financial administration of the GDUFA program to help
identify areas to enhance operational and fiscal efficiency. FDA will also conduct
activities to enhance transparency of how GDUFA program resources are used.
2. FDA will publish a GDUFA 5-year financial plan no later than the second quarter of
FY 2023. FDA will publish updates to the 5-year plan no later than the second quarter
of each subsequent fiscal year.
3. FDA will convene a public meeting no later than the third quarter of each fiscal year
starting in FY 2024 to discuss the GDUFA 5-year financial plan, along with the

40

Agency’s progress in implementing modernized time reporting and resource
management planning.
E. Improving the Hiring of Review Staff
1. Enhancements to the generic drug review program require that FDA hire the
necessary technical and scientific experts to efficiently conduct assessments of
generic drug applications and supporting activities. 
2. During GDUFA III, FDA will:  
a. Hire 128 staff for the generic drug review program in FY 2023; and
b. Confirm progress in the hiring of GDUFA III staff in the GDUFA 5year financial plan.
IX. GUIDANCE AND MAPPS
A. FDA will draft or modify relevant Manuals of Policies and Procedures (MAPPs) to
reflect the commitments and goals in this Commitment Letter, including, but not limited
to, the following:
1. To direct project managers, assessors, and other assessment program staff to actively
work towards an action for an ANDA with a missed or extended goal date.
2. To revise MAPP 5200.12 Communicating Abbreviated New Drug Application
Review Status Updates with Industry, to include communications related to imminent
actions on or before April 30, 2023.
B. FDA will issue a Federal Register Notice on or before April 30, 2023, to solicit public
comment on the content of Appendix A in the guidance for industry on ANDA
Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA (July
2018) and will use evaluations and/or training to assure consistency in ANDA
amendment classification.
C. FDA will issue a MAPP on the process for Reclassification of Facility-Based Major CRL
Amendments set forth in section II(C)(7) on or before June 30, 2024.
D. FDA will issue a MAPP on the prioritization of FDA assessment of solicited DMF
amendments described in section VI(F)(2) on or before June 30, 2024.
E. FDA will issue guidance clarifying the regulatory status of active pharmaceutical
ingredient-excipient mixtures for GDUFA purposes.

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X. PERFORMANCE REPORTING
A. Monthly Reporting Metrics: FDA will publish the following monthly metrics on its
website, using a consistent, publicly disclosed reporting methodology:
1. Number of ANDAs and amendments, CBE supplements, and PASs submitted in the
reporting month delineated by type of submission:
2. Number of ANDAs and PASs FDA refused for receipt in the reporting month:
3. Number of actions taken in the reporting month delineated by the type of action. For
purposes of the metrics, actions shall include final approvals, tentative approvals,
CRLs, IRs, and DRLs (or other such nomenclature as FDA determines to reflect the
concepts of an information request or CRL):
4. Number of finalized DMF Completeness Assessments in the reporting month;
5. Number of DMF fees paid in the reporting month; and
6. Number of first-cycle approvals and tentative approvals in the reporting month.
B. Quarterly Reporting Metrics: FDA will publish the following quarterly metrics on its
website, using a consistent, publicly disclosed reporting methodology:
1. Number of ANDAs and PASs withdrawn in each reporting month;
2. Number of ANDAs awaiting applicant action;
3. Number of ANDAs awaiting FDA action;
4. Mean and median approval and tentative approval times for the quarterly action
cohort,
5. Number of original ANDAs for Complex Generic Products submitted;
6. Number of requests for reclassification of a Facility-Based Major CRL Amendment
received, and number of requests granted and denied; and
7. Number of Level 1 and Level 2 Controlled Correspondence submitted.
C. Fiscal Year Performance Report Metrics: FDA will publish the following metrics
annually as part of the GDUFA Performance Report:
1. Mean and median approval and tentative approval times for ANDAs by FY receipt
cohort;

42

2. Mean and median ANDA approval times, including separate reporting of mean and
median times for first-cycle approvals FY receipt cohort;
3. Mean and median number of ANDA assessment cycles to approval and tentative
approval by FY receipt cohort;
4. Number of applications received and refused to receive, and average time to receipt
decision;
5. Number of GDUFA-related meetings and teleconferences requested, granted, denied,
and conducted, broken down by type of meeting or teleconference, and in addition for
Post-Warning Letter Meetings, the number deferred in favor of re-inspection;
6. Number of inspections conducted by domestic or foreign establishment location and
inspection type (preapproval inspection, surveillance, bioequivalence clinical and
bioequivalence analytical) and facility type (finished dosage form, API);
7. Median time from beginning of inspection to Form FDA 483 issuance;
8. Median time from Form FDA 483 issuance to Warning Letter, Import Alert and
Regulatory Meeting for inspections with final classification of “Official Action
Indicated” (or equivalent),
9. Median time from date of Warning Letter, Import Alert or Regulatory Meeting to
resolution of the “Official Action Indicated” status (or equivalent);
10. Number of ANDAs accepted for standard assessment and priority assessment;
11. Percentage of suitability petitions completed within 6 months after FDA completes
the completeness assessment, the total number submitted, and total number
completed;
12. Number of citizen petitions to determine whether a listed drug has been voluntarily
withdrawn from sale for reasons of safety or effectiveness pending a substantive
response for more than 270 days from the date of receipt;
13. Percentage of ANDA proprietary name requests evaluated within 180 days of receipt;
14. Number of DMF First Adequate Letters issued;
15. Number of teleconferences granted, and number of email exchanges requested and
conducted in lieu of teleconferences to clarify deficiencies in first cycle DMF
deficiency letters;

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16. Percent of PSGs for non-Complex Product NCE NDAs within two years of NDA
approval;
17. Percent of PSGs for Complex Product NDAs, including NCEs, published within two
and three years of NDA approval;
18. Percentage of facility re-inspections carried out within 4 or 8 months after the letter to
the facility indicating FDA’s intent to reinspect for domestic or foreign facilities,
respectively;
19. For the total number of original ANDAs, amendments, PASs, PAS amendments, and
meeting requests submitted in a fiscal year, FDA will publish the number of actions
completed (as of the annual publication date), and the percent completed by the goal
date. FDA also will publish this data annually on its website, further enumerated by
goal-date subcategory, and will include metrics regarding timeframes for acting on
meeting requests;
a. For example, in the GDUFA Performance Report, the priority PAS submission
goal will be reported as the number of actions and the percent completed
combined for the 4-, 8- and 10-month goals
b. For the Annual Web Posting, the priority PAS submission goals will be reported
as the number of actions and the percent completed individually for the 4-, 8- and
10-month goals; and
20. Percent Controlled Correspondence Level 1 and Level 2 responded to within the
applicable goal date (i.e., 60 and 120 days, respectively);
21. Number of missed goal dates for original ANDAs by more than 6, 9, and 12 months.
D. Fiscal Year Web Posting
In addition to the data that will be reported annually on the web described in section
XI(C)(19), FDA will also post the following data annually on its website:
1. The number of requests for review of a DMF prior to ANDA or PAS submission, as
describe in sections VI(E)(1) and VI(E)(2), the number granted, and the number
completed;
2. Number of priority and non-priority “off-cycle” solicited DMF amendments reviewed
as described in section VI(F); and
3. Number of original approvals taken that are Imminent Actions.

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XI. DEFINITIONS
A. Act on – with respect to an application, means FDA will either issue a CRL, an approval,
a tentative approval, or a refuse-to-receive action.
B. Ambiguity in the Controlled Correspondence response – means the Controlled
Correspondence response or a critical portion of it merits further clarification.
C. Review Status Update – means a response from the RPM to the applicant to update the
applicant concerning, at a minimum, the categorical status of relevant assessment
disciplines with respect to the submission at that time. The RPM will advise the applicant
that the update is preliminary only, based on the RPM’s interpretation of the submission,
and subject to change at any time.
D. Capacity Planning Adjustment – Methodology that annually adjusts inflation-adjusted
target revenue to account for additional resource needs due to sustained increases in
workload for the GDUFA program.
E. Complete Response Letter– refers to a written communication to an applicant or DMF
holder from FDA usually describing all of the deficiencies that the Agency has identified
in an ANDA (including pending amendments) or a DMF that must be satisfactorily
addressed before the ANDA can be approved. Complete response letters will reflect a
Complete Assessment, which includes an application-related facilities assessment and
will require a complete response from industry to restart the clock. Refer to 21 CFR
314.110 for additional details. When a citizen petition may impact the approvability of
the ANDA, FDA will strive to address, where possible, valid issues raised in a relevant
citizen petition in the complete response letter. If a citizen petition raises an issue that
would delay only part of a complete response, a response that addresses all other issues
will be considered a complete response.
F. Complete Assessment – refers to a full division-level assessment from all relevant
assessment disciplines, including inspections, and includes other matters relating to the
ANDAs and associated DMFs as well as consults with other Agency components.
G. Complex Product – generally includes:
1. Products with complex active ingredients (e.g., peptides, polymeric compounds,
complex mixtures of APIs, naturally sourced ingredients); complex formulations
(e.g., liposomes, colloids); complex routes of delivery (e.g., locally acting drugs such
as dermatological products, complex ophthalmological products, and otic dosage
forms that are formulated as suspensions, emulsions or gels) or complex dosage
forms (e.g., transdermal systems, metered dose inhalers, extended release injectables)

45

2. Complex drug-device combination products (e.g., pre-filled auto-injector products,
metered dose inhalers); and
3. Other products where complexity or uncertainty concerning the approval pathway or
possible alternative approach would benefit from early scientific engagement.
H. Complex Generic Product – refers to a generic version of a Complex Product.
I. Controlled Correspondence - Level 1 – means correspondence submitted to the
Agency, by or on behalf of a generic drug manufacturer or related industry:
1. Requesting information on a specific element of generic drug product development:
a. Prior to ANDA submission;
b. After a PSG Teleconference if a prospective applicant or applicant seeks further
feedback from FDA;
c. After issuance of a CRL or tentative approval;
d. After ANDA approval; or
2. Concerning post-approval submission requirements that are not covered by CDER
post-approval changes guidance and are not specific to an ANDA.
J. Controlled Correspondence - Level 2 – means correspondence that meets the definition
of Level 1 correspondence, and:
1. Involves evaluation of clinical content;
2. Requests a Covered Product Authorization and review of bioequivalence protocols
for development and testing that involves human clinical trials for an ANDA where
the RLD is subject to a Risk Evaluation and Mitigation Strategy (REMS) with
Elements to Assure Safe Use (ETASU);
3. Requests a Covered Product Authorization to obtain sufficient quantities of an
individual covered product subject to a REMS with ETASU when development and
testing does not involve clinical trials;
4. Requests evaluations of alternative bioequivalence approaches (e.g., pharmacokinetic,
in vitro, clinical); or
5. Requires input from another office or center, e.g., questions regarding device
constituent parts of a combination product.

46

K. Covered Product Authorization – a letter from FDA authorizing an eligible product
developer to obtain sufficient quantities of an individual covered product subject to a
REMS with ETASU for product development and testing purposes, as described in
section 610 of Division N of the Further Consolidated Appropriations Act, 2020 (21
U.S.C. 355-2), commonly referred to as the “CREATES Act.”
L. Days – unless otherwise specified, means calendar days.
M. Discipline Review Letter – means a letter used to convey preliminary thoughts on
possible deficiencies found by a discipline assessor and/or assessment team for its portion
of the pending application at the conclusion of the discipline assessment.
N. Earliest lawful ANDA approval date – the first date on which no patent or exclusivity
prevents approval of an ANDA.
O. First Adequate Letter – a communication from FDA to DMF holder indicating that the
DMF has no open issues related to the assessment of the referencing ANDA. This
communication is issued only at the conclusion of the first DMF assessment cycle that
determines the DMF does not have any open issues.
P. First Generic – any received ANDA: (1) for a First Applicant as described in section
505(j)(5)(B)(iv)(II)(bb) of the FD&C Act or for which there are no blocking patents or
exclusivities; and (2) for which there is no previously approved ANDA for the drug
product.
Q. Information Request – means a communication that is sent to an applicant during an
assessment to request further information or clarification that is needed or would be
helpful to allow completion of the discipline assessment.
R. Major Amendment – means a Major Amendment as described in the guidance for
industry on ANDA Submissions — Amendments to Abbreviated New Drug Applications
Under GDUFA (July 2018), and any subsequent revision.
S. Mid-point of assessment cycle – The mid-point of an assessment cycle is half the length
of an assessment period plus or minus 30 days.
T. Minor Amendment – means a minor amendment as described in the guidance for
industry on ANDA Submissions — Amendments to Abbreviated New Drug Applications
Under GDUFA (July 2018), and any subsequent revision.
U. Priority – means submissions affirmatively identified as eligible for expedited
assessment pursuant to MAPP 5240.3, Prioritization of the Review of Original ANDAs,
Amendments and Supplements, as revised (the CDER Prioritization MAPP).

47

V. Significant Major deficiency – means a major deficiency, the resolution of which is
required before the continued assessment by multiple disciplines, e.g., a reformulation,
or a major deficiency that impacts the test drug product used in a bioequivalence study.
W. Small Issue – for the purposes of Imminent Actions in section II(B)(3), means a
deficiency that can be assessed by FDA within 60 days because it can be addressed by:
1) a clarification of scientific information regarding data already submitted, 2) the
limited submission of additional data, or 3) the submission of administrative
information (e.g., completion of a form or a change in an address).
X. Standard – means submissions not affirmatively identified as eligible for expedited
assessment pursuant to the CDER Prioritization MAPP.
Y. Teleconference – means a verbal communication by telephone, and not a written
response, unless otherwise agreed to by the applicant.
Z. Unsolicited Amendment – an amendment with information not requested by FDA
except for those unsolicited amendments considered routine or administrative in nature
that do not require scientific review (e.g., requests for final ANDA approval, patent
amendments, and general correspondence).

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Appendix: Prioritization of Suitability Petitions
Prior to GDUFA III, FDA received approximately 20-30 suitability petitions per year and had
approximately 170 suitability petitions currently pending as of July 2021. Pursuant to this
Commitment Letter, in GDUFA III FDA has agreed to set goal dates for review and response to
suitability petitions. To receive a goal date, pending petitions submitted prior to FY 2024 must
be withdrawn and resubmitted.
If FDA does not respond to all petitions submitted in a given fiscal year, FDA has committed to
prioritizing suitability petitions that are carried over to the following fiscal year over new
petitions received in that fiscal year (subject to the prioritization outlined in section III(B)(6)).
The following hypothetical example describes how FDA will prioritize suitability petitions if
FDA is unable to respond to all suitability petitions in a given fiscal year. This example assumes
a significantly higher number of incoming petitions and a high number of carryover petitions to
illustrate how petitions that are carried over will be prioritized.
Example
For FY 2024, FDA’s goal is to respond to 50 percent of all suitability petitions received within
six months of the completeness assessment, up to a maximum of 50 suitability petitions. In FY
2024, FDA receives and performs the completeness assessment for 100 suitability petitions. To
meet the goal, FDA must respond to 50 of those petitions within six months after the
completeness assessment. At the end of FY 2024, FDA has responded to 50 petitions within 6
months, and 10 in greater than six months. FDA therefore met the FY 2024 goal of 50 percent
within six months (i.e., 50 petitions), and the additional 40 petitions still pending roll into FY
2025.
For FY 2025, FDA’s goal is to respond to 70 percent of all suitability petitions received within
six months of the completeness assessment, up to a maximum of 70 suitability petitions. In FY
2025, FDA receives 40 suitability petitions. To meet the FY 2025 goal, FDA must respond to 28
of those petitions within six months of the completeness assessment. FDA will prioritize any
suitability petitions received in FY 2025 prioritized as outlined in section III(B)(6) and the 40
pending petitions from FY 2024 over any other suitability petitions received in FY25, in that
order. By the end of FY 2025, FDA has responded to all 40 petitions from the FY 2024 cohort
and 28 of the 40 from FY 2025 within 6 months of the completeness assessment. Twelve
petitions from the FY 2025 cohort remain pending. FDA has met the FY 2025 goal, and the
remaining 12 petitions still pending will be carried over into FY 2026 and prioritized.

49