0429 GFI PDUFA Meetings

Formal Meetings
Between the FDA and
Sponsors or Applicants
of PDUFA Products
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to https://www.regulations.gov. Submit written
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the
docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact (CDER) Rachel Kichline at 301-796-0319
or (CBER) the Office of Communication, Outreach, and Development at 800-835-4709 or 240402-8010. 

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
December 2017
Procedural

15549dft.doc
12/18/2017

Formal Meetings
Between the FDA and
Sponsors or Applicants
of PDUFA Products
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: [email protected]
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
Office of Communication, Outreach, and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, rm. 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010; Email: [email protected]
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
December 2017
Procedural

TABLE OF CONTENTS
I. 

INTRODUCTION............................................................................................................. 1 

II. 

BACKGROUND ............................................................................................................... 2 

III. 

MEETING TYPES ........................................................................................................... 2 

A.  Type A Meeting .............................................................................................................................. 2 
B. 

Type B Meeting .............................................................................................................................. 3 

C.  Type B (EOP) Meeting .................................................................................................................. 4 
D.  Type C Meeting .............................................................................................................................. 4 

IV. 

MEETING FORMATS .................................................................................................... 4 

V. 

MEETING REQUESTS ................................................................................................... 4 

VI. 

ASSESSING AND RESPONDING TO MEETING REQUESTS ................................ 7 

A.  Meeting Denied .............................................................................................................................. 7 
B. 

Meeting Granted ............................................................................................................................ 8 

VII. 

MEETING PACKAGE .................................................................................................... 9 

A.  Timing of Meeting Package Submission ...................................................................................... 9 
B. 

Where and How Many Copies of Meeting Packages to Send .................................................. 10 

C.  Meeting Package Content............................................................................................................ 10 

VIII.  PRELIMINARY RESPONSES ..................................................................................... 12 
IX. 

RESCHEDULING AND CANCELING MEETINGS ................................................ 12 

X. 

MEETING CONDUCT .................................................................................................. 14 

XI. 

MEETING MINUTES.................................................................................................... 14 

REFERENCES............................................................................................................................ 16 
APPENDIX: SUMMARY OF MEETING MANAGEMENT PROCEDURAL GOALS .... 17 

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Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA Products
Guidance for Industry1

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This draft guidance, when finalized, will represent the current thinking of the Food and Drug
Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible
for this guidance as listed on the title page.

I.

INTRODUCTION

This guidance provides recommendations to industry on formal meetings between the Food and
Drug Administration (FDA) and sponsors or applicants relating to the development and review
of drug or biological drug products (hereafter referred to as products) regulated by the Center for
Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research
(CBER). This guidance does not apply to abbreviated new drug applications, applications for
biosimilar biological products, or submissions for medical devices. For the purposes of this
guidance, formal meeting includes any meeting that is requested by a sponsor or applicant
(hereafter referred to as requester(s)) following the procedures provided in this guidance and
includes meetings conducted in any format (i.e., face to face, teleconference/videoconference, or
written response only (WRO)).
This guidance discusses the principles of good meeting management practices (GMMPs) and
describes standardized procedures for requesting, preparing, scheduling, conducting, and
documenting such formal meetings. The general principles in this guidance may be extended to
other nonapplication-related meetings with external constituents, insofar as this is possible.2
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of

1

This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the
Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.
2

The previous guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants published May
19, 2009, and the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of
PDUFA Products published March 11, 2015, have been withdrawn.

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the word should in Agency guidances means that something is suggested or recommended, but
not required.

II.

BACKGROUND

Each year, FDA review staff participate in many meetings with requesters who seek advice
relating to the development and review of investigational new drugs and biologics, and drug or
biological product marketing applications. Because these meetings often represent critical points
in the regulatory process, it is important that there are efficient, consistent procedures for the
timely and effective conduct of such meetings. The GMMPs in this guidance are intended to
provide consistent procedures that will promote well-managed meetings and to ensure that such
meetings are scheduled within a reasonable time, conducted efficiently, and documented
appropriately.
FDA review staff and requesters adhere to the meeting management goals that were established
under reauthorizations of the Prescription Drug User Fee Act (PDUFA).3 They are described
individually throughout this guidance and summarized in the Appendix.
MEETING TYPES4

III.

There are four types of formal meetings under PDUFA that occur between requesters and FDA
staff: Type A, Type B, Type B (end of phase (EOP)), and Type C.
A.

Type A Meeting

Type A meetings are those that are necessary for an otherwise stalled product development
program to proceed or to address an important safety issue. Examples of a Type A meeting
include:


Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in
the guidance for industry and review staff Formal Dispute Resolution: Sponsor Appeals
Above the Division Level.5

3

See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022 available at
https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.

4
The meeting types and goal dates were negotiated under the Prescription Drug User Fee Act (PDUFA) and apply
to formal meetings between FDA staff and requesters of PDUFA products; they do not apply to meetings with
CDER Office of Generic Drugs, CDER Office of Compliance, or CDER Office of Prescription Drug Promotion.
See the Prescription Drug User Fee Act (PDUFA) web page at
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm.
5

We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA
Drugs guidance web page at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

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

Meetings to discuss clinical holds: (1) in which the requester seeks input on how to
address the hold issues; or (2) in which a response to hold issues has been submitted, and
reviewed by the FDA, but the FDA and the requester agree that the development is
stalled and a new path forward should be discussed.



Meetings that are requested after receipt of an FDA Nonagreement Special Protocol
Assessment letter in response to protocols submitted under the special protocol
assessment procedures as described in the guidance for industry Special Protocol
Assessment.



Post-action meetings requested within 3 months after an FDA regulatory action other
than an approval (i.e., issuance of a complete response letter).



Meetings requested within 30 days of FDA issuance of a refuse-to-file letter. To file an
application over protest, applicants must avail themselves of this meeting (21 CFR
314.101(a)(3)).

Before submitting a Type A meeting request, requesters should contact the review division or
office to discuss the appropriateness of the request.
B.

Type B Meeting

Type B meetings are as follows:


Pre-investigational new drug application (pre-IND) meetings.



Pre-emergency use authorization meetings.



Pre-new drug application (pre-NDA)/pre-biologics license application (pre-BLA)
meetings (21 CFR 312.47).



Post-action meetings requested 3 or more months after an FDA regulatory action other
than an approval (i.e., issuance of a complete response letter).



Meetings regarding risk evaluation and mitigation strategies or postmarketing
requirements that occur outside the context of the review of a marketing application.



Meetings held to discuss the overall development program for products granted
breakthrough therapy designation status. Subsequent meetings for breakthrough therapydesignated products will be considered either Type B or possibly Type A meetings if the
meeting request meets the criteria for a Type A meeting.

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C.

Type B (EOP) Meeting

Type B (EOP) meetings are as follows:


Certain end-of-phase 1 meetings (i.e., for products that will be considered for marketing
approval under 21 CFR part 312, subpart E, or 21 CFR part 314, subpart H, or similar
products)



End-of-phase 2 or pre-phase 3 meetings (21 CFR 312.47)
D.

Type C Meeting

A Type C meeting is any meeting other than a Type A, Type B, or Type B (EOP) meeting
regarding the development and review of a product, including meetings to facilitate early
consultations on the use of a biomarker as a new surrogate endpoint that has never been
previously used as the primary basis for product approval in the proposed context of use.

IV.

MEETING FORMATS

There are three meeting formats: face to face, teleconference/videoconference, and WRO as
follows:
(1) Face to face — Traditional face-to-face meetings are those in which the majority of
attendees participate in person at the FDA
(2) Teleconference/Videoconference — Teleconferences/videoconferences are meetings in
which the attendees participate from various remote locations via an audio (e.g.,
telephone) and/or video connection
(3) Written response only — WRO responses are sent to requesters in lieu of meetings
conducted in one of the other two formats described above

V.

MEETING REQUESTS

To make the most efficient use of FDA resources, before seeking a meeting, requesters should
use the extensive sources of product development information that are publically available. To
disseminate a broad range of information in a manner that can be easily and rapidly accessed by
interested parties, the FDA develops and maintains web pages, portals, and databases, and
participates in interactive media as a means of providing advice on scientific and regulatory
issues that fall outside of established guidance, policy, and procedures.
To promote efficient meeting management, requesters should try to anticipate future needs and,
to the extent practical, combine product development issues into the fewest possible meetings.

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When a meeting is needed, a written request must be submitted to the FDA via the respective
center’s document room (paper submissions) or via the electronic gateway, as appropriate.6
Requests should be addressed to the appropriate review division or office and, if previously
assigned, submitted to the application (e.g., investigational new drug application (IND), new
drug application (NDA), biologics license application (BLA)). Meeting requests sent by fax or
email are considered courtesy copies only and are not a substitute for a formal submission.
The meeting request should include adequate information for the FDA to assess the potential
utility of the meeting and to identify FDA staff necessary to discuss proposed agenda items.
The meeting request should include the following information:
1. The application number (if previously assigned).
2. The product name.
3. The chemical name, established name, and/or structure.
4. The proposed regulatory pathway (e.g., 505(b)(1), 505(b)(2)).
5. The proposed indication(s) or context of product development.
6. The meeting type being requested (i.e., Type A, Type B, Type B (EOP), or Type C).
7. Pediatric study plans, if applicable.
8. Human factors engineering plan, if applicable.
9. Combination product information (e.g., constituent parts, including details of the device
constituent part, intended packaging, planned human factors studies), if applicable.
10. Suggested dates and times (e.g., morning or afternoon) for the meeting that are consistent
with the appropriate scheduling time frame for the meeting type being requested (see
Table 2 in section VI.B., Meeting Granted). Dates and times when the requester is not
available should also be included.
11. A list of proposed questions, grouped by FDA discipline. For each question there should
be a brief explanation of the context and purpose of the question.

6
See the guidance for industry Providing Regulatory Submissions in Electronic Format — Submissions Under
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.

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The meeting request must include the following information:7
1. The proposed meeting format (i.e., face to face, teleconference/videoconference, or
WRO).
2. The date the meeting background package will be sent by the requester (see section
VII.A., Timing of Meeting Package Submission). Note that meeting packages should be
included with the meeting request for all Type A meetings and those Type C meetings
where the objective is to facilitate early consultation on the use of a biomarker as a new
surrogate endpoint that has never been previously used as the primary basis for product
approval in the proposed context of use.
3. A brief statement of the purpose of the meeting. This statement should include a brief
background of the issues underlying the agenda. It also can include a brief summary of
completed or planned studies and clinical trials or data that the requester intends to
discuss at the meeting, the general nature of the critical questions to be asked, and where
the meeting fits in overall development plans. Although the statement should not provide
the details of trial designs or completed studies and clinical trials, it should provide
enough information to facilitate understanding of the issues, such as a small table that
summarizes major results.
4. A list of the specific objectives or outcomes the requester expects from the meeting.
5. A proposed agenda, including estimated times needed for discussion of each agenda item.
6. A list of planned attendees from the requester’s organization, including their names and
titles. The list should also include the names, titles, and affiliations of consultants and
interpreters, if applicable.
7. A list of requested FDA attendees and/or discipline representative(s). Note that requests
for attendance by FDA staff who are not otherwise essential to the application’s review
may affect the ability to hold the meeting within the specified time frame of the meeting
type being requested. Therefore, when attendance by nonessential FDA staff is
requested, the meeting request should provide a justification for such attendees and state
whether or not a later meeting date is acceptable to the requester to accommodate the
nonessential FDA attendees.
When submitting a meeting request, the requester should define the specific areas of input
needed from the FDA. A well-written meeting request that includes the above components can
help the FDA understand and assess the utility and timing of the meeting related to product
development or review. The list of requester attendees and the list of requested FDA attendees
can be useful in providing or preparing for the input needed at the meeting. However, during the
time between the request and the meeting, the planned attendees can change. Therefore, an
7

See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022 available at
https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.

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updated list of attendees with their titles and affiliations should be included in the meeting
package and a final list provided to the appropriate FDA contact before the meeting (see section
VII.C., Meeting Package Content).
The objectives and agenda provide overall context for the meeting topics, but it is the list of
questions that is most critical to understanding the kind of information or input needed by the
requester and to focus the discussion should the meeting be granted. Each question should be
precise and include a brief explanation of the context and purpose of the question. The questions
submitted within a single meeting request should be limited to those that can be reasonably
answered within the allotted meeting time, taking into consideration the complexity of the
questions submitted. Similar considerations regarding the complexity of questions submitted
within a WRO should be applied.

VI.

ASSESSING AND RESPONDING TO MEETING REQUESTS

Although requesters can request any meeting format for any meeting type, the FDA assesses
each meeting request, including WRO requests, and determines whether or not the request
should be granted, the final meeting type, and the appropriate meeting format. The FDA may
determine that a WRO is the most appropriate means for providing feedback and advice for preIND and most Type C meetings, except for Type C meetings to discuss the use of a biomarker as
a new surrogate endpoint when that endpoint has never been previously used as the primary basis
for product approval, which will be conducted face to face. If the FDA decides that another
meeting format is needed instead of sending responses by WRO, it will notify the requester as
described in section VI.B., Meeting Granted.
Requests for Type B and Type B (EOP) meetings will be honored except in unusual
circumstances. Generally, with the exception of products granted breakthrough therapy
designation status, the FDA will not grant more than one of each of the Type B meetings for
each potential application (e.g., IND, NDA, BLA) or combination of closely related products
developed by the same requester (e.g., same active ingredient but different dosage forms being
developed concurrently), but the FDA can do so when it would be beneficial to hold separate
meetings to discuss unrelated issues. For example, it may be appropriate to conduct more than
one end-of-phase 2 meeting with different review divisions for concurrent development of a
product for unrelated claims or a separate meeting to discuss manufacturing development when
the clinical development is on a different timeline.
A.

Meeting Denied

If a meeting request is denied, the FDA will notify the requester in writing according to the
timelines described in Table 1. The FDA’s letter will include an explanation of the reason for
the denial. Denials will be based on a substantive reason, not merely on the absence of a minor
element of the meeting request or meeting package items. For example, a meeting can be denied
because it is premature for the stage of product development or because the meeting package
does not provide an adequate basis for the meeting discussion. Thus, the FDA will generally
deny requests for Type A meetings and Type C meetings to discuss the use of a biomarker as a

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new surrogate endpoint that has never been previously used as the primary basis for product
approval that do not include an adequate meeting package in the original request (see section IX.,
Rescheduling and Canceling Meetings, for the effect of inadequate meeting packages on other
meeting types where the package is received after the meeting is granted). The FDA may also
deny requests for meetings that do not have substantive required elements described in section
V., Meeting Requests. A subsequent request to schedule the meeting will be considered as a new
request (i.e., a request that merits a new set of time frames as described in section III., Meeting
Types).
B.

Meeting Granted

If a meeting request is granted, the FDA will notify the requester in writing according to the
timelines described in Table 1. For face-to-face and teleconference/videoconference meetings,
the FDA’s letter will include the date, time, conferencing arrangements and/or location of the
meeting, as well as expected FDA participants. For WRO requests, the FDA’s letter will include
the date the FDA intends to send the written responses (see Table 3 for FDA WRO response
timelines). As shown in Tables 2 and 3, FDA WRO response timelines are the same as those for
scheduling a meeting (face to face or teleconference/videoconference) of the same meeting type.
For face-to-face and teleconference/videoconference meetings, the FDA will schedule the
meeting on the next available date at which all expected FDA staff are available to attend;
however, the meeting should be scheduled consistent with the type of meeting requested (see
Table 2 for FDA meeting scheduling time frames). If the requested date for any meeting type is
greater than the specified time frame, the meeting date should be within 14 calendar days of the
requested date.
Table 1: FDA Meeting Request/WRO Request Response Timelines
Meeting Type
Response Time
(any format)
(calendar days from receipt of
meeting request/WRO request)
A
14 days
B
21 days
B (EOP)
14 days
C
21 days
Table 2: FDA Meeting Scheduling Time Frames
Meeting Type
Meeting Scheduling
(calendar days from receipt of
meeting request)
A
30 days
B
60 days
B (EOP)
70 days
C
75 days

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Table 3: FDA WRO Response Timelines
Meeting Type
WRO Response Time
(calendar days from receipt of
WRO request)
A
30 days
B
60 days
B (EOP)
70 days
C
75 days

VII.

MEETING PACKAGE

Premeeting preparation is critical for achieving a productive discussion or exchange of
information. Preparing the meeting package should help the requester focus on describing its
principal areas of interest. The meeting package should provide information relevant to the
discussion topics and enable the FDA to prepare adequately for the meeting. In addition, the
timely submission of the meeting package is important for ensuring that there is sufficient time
for meeting preparation, accommodating adjustments to the meeting agenda, and accommodating
appropriate preliminary responses to meeting questions.
A.

Timing of Meeting Package Submission

Requesters must submit the meeting package for each meeting type (including WRO) according
to the meeting package timelines described in Table 4.8
Table 4: Requester Meeting Package Timelines
Meeting
FDA Receipt of Meeting Package (calendar days)
Type
A, C*
At the time of the meeting request
B
No later than 30 days before the scheduled date of the meeting
or WRO response time
B (EOP) No later than 50 days before the scheduled date of the meeting
or WRO response time**
C
No later than 47 days before the scheduled date of the meeting
or WRO response time***
*For Type C meetings that are requested as early consultations on the use of a new surrogate endpoint to be used as
the primary basis for product approval in a proposed context of use, the meeting package is due at the time of the
meeting request.
** If the scheduled date of a Type B (EOP) meeting is earlier than 70 days from FDA receipt of the meeting request,
the requester’s meeting package will be due no sooner than 6 calendar days after FDA response time for issuing the
letter granting the meeting (see Table 1 in section VI.B., Meeting Granted).
*** If the scheduled date of a Type C meeting is earlier than 75 days from FDA receipt of the meeting request, the
meeting package will be due no sooner than 7 calendar days after FDA response time for issuing the letter granting
the meeting (see Table 1 in section VI.B., Meeting Granted).
8
See PDUFA Reauthorization Performance Goals and Procedures available at
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm149212.htm.

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B.

Where and How Many Copies of Meeting Packages to Send

Requesters should submit the archival meeting package to the relevant application(s) (e.g., IND,
NDA, or BLA) via the appropriate center’s document room (paper submission) or via the
electronic gateway, as applicable.9
To facilitate the meeting process, CDER strongly suggests that copies of meeting packages
provided in electronic format also be provided in paper (desk copies). The number of desk
copies of a meeting package will vary based on the meeting. The CDER project manager will
advise on the number of desk copies needed for the meeting attendees. CBER neither requests
nor accepts paper copies (desk copies) of meeting packages that have been submitted in
electronic format.
C.

Meeting Package Content

The meeting package should provide summary information relevant to the product and any
supplementary information needed to develop responses to issues raised by the requester or
review division. It is critical that the entire meeting package content support the intended
meeting objectives. The meeting package content will vary depending on the product,
indication, phase of product development, and issues to be discussed. FDA and ICH guidances
identify and address many issues related to product development and should be considered when
planning, developing, and providing information needed to support a meeting with the FDA. If a
product development plan deviates from current guidances, or from current practices, the
deviation should be recognized and explained. Known difficult design and evidence issues
should be raised for discussion (e.g., use of a surrogate endpoint, reliance on a single study, use
of a noninferiority design, adaptive designs). Also, merely describing a result as significant does
not provide the review division with enough information to give good advice or identify
important problems the requester may have missed.
To facilitate FDA review, the meeting package content should be organized according to the
proposed agenda. The meeting package should be a sequentially paginated document with a
table of contents, appropriate indices, appendices, and cross references. It should be tabbed or
bookmarked to enhance reviewers’ navigation across different sections within the package, both
in preparation for and during the meeting. Meeting packages generally should include the
following information, preferably in the order listed below:
1. The application number (if previously assigned).
2. The product name.
3. The chemical name, established name, and/or structure.
9

See the guidances for industry Providing Regulatory Submissions in Electronic Format — Submissions Under
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act and Providing Regulatory Submissions in Electronic
Format — General Considerations.

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389
390
391
392
393
394
395
396
397
398
399
400
401
402
403
404
405
406
407
408
409
410
411
412
413
414
415
416
417
418
419
420
421
422
423
424
425
426
427
428
429
430
431
432
433
434

4. The proposed regulatory pathway (e.g., 505(b)(1), 505(b)(2)).
5. The proposed indication(s) or context of product development.
6. The dosage form, route of administration, and dosing regimen (frequency and duration).
7. Pediatric study plans, if applicable.
8. Human factors engineering plan, if applicable.
9. Combination product information (e.g., constituent parts, including details of the device
constituent part, intended packaging, planned human factors studies), if applicable.
10. A list of all individuals, with their titles and affiliations, who will attend the requested
meeting from the requester’s organization, including consultants and interpreters.
11. A background section that includes the following:
a. A brief history of the development program and relevant communications with the
FDA before the meeting
b. Substantive changes in product development plans (e.g., new indication, population,
basis for a combination), when applicable
c. The current status of product development
12. A brief statement summarizing the purpose of the meeting and identifying the type of
milestone meeting, if applicable.
13. A proposed agenda, including estimated times needed for discussion of each agenda item.
14. A list of the final questions for discussion grouped by FDA discipline and with a brief
summary for each question to explain the need or context for the question. Questions
regarding combination products should be grouped together.
15. Data to support discussion organized by FDA discipline and question. Protocols, full
study reports, or detailed data generally are not appropriate for meeting packages; the
summarized material should describe the results of relevant studies and clinical trials with
some degree of quantification, and any conclusion about clinical trials that resulted. The
trial endpoints should be stated, as should whether endpoints were altered or analyses
changed during the course of the trial.
For example, for an end-of-phase 2 meeting, this section of the meeting package should
include the following: a description and the results of controlled trials conducted to
determine dose-response information; adequately detailed descriptors of planned phase 3

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435
436
437
438
439
440
441
442
443
444
445
446
447
448
449
450
451
452
453
454
455
456
457
458
459
460
461
462
463
464
465
466
467
468
469
470
471
472
473
474
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476
477

trials identifying major trial features such as population, critical exclusions, trial design
(e.g., randomization, blinding, and choice of control group, with an explanation of the
basis for any noninferiority margin if a noninferiority trial is used), dose selection, and
primary and secondary endpoints; and major analyses (including planned interim
analyses and adaptive features, and major safety concerns).

VIII. PRELIMINARY RESPONSES
Communications before the meeting between requesters and the FDA, including preliminary
responses, can serve as a foundation for discussion or as the final meeting responses.
Nevertheless, preliminary responses should not be construed as final unless there is agreement
between the requester and the FDA that additional discussion is not necessary for any question
(i.e., when the meeting is canceled because the requester is satisfied with the FDA’s preliminary
responses), or a particular question is considered resolved allowing extra time for discussion of
the more complex questions during the meeting. Preliminary responses communicated by the
FDA are not intended to generate the submission of new information or new questions. If a
requester nonetheless provides new data or a revised or new proposal, the FDA may not be able
to provide comments on the new information or it may necessitate the submission of a new
meeting request by the requester.
The FDA holds an internal meeting to discuss the content of meeting packages and to gain
internal alignment on the preliminary responses. The FDA will send the requester its
preliminary responses to the questions in the meeting package no later than 5 calendar days
before the meeting date for Type B (EOP) and Type C meetings. The requester will notify the
FDA no later than 3 calendar days following receipt of the FDA’s preliminary responses for
these meeting types of whether the meeting is still needed, and if it is, the requester will send the
FDA a revised meeting agenda indicating which questions the requestor considers as resolved,
and which questions the requestor will want to further discuss.10 For all other meeting types, the
FDA intends to send the requester its preliminary responses no later than 2 calendar days before
the meeting.

IX.

RESCHEDULING AND CANCELING MEETINGS

Occasionally, circumstances arise that necessitate the rescheduling or cancellation of a meeting.
If a meeting needs to be rescheduled, it should be rescheduled as soon as possible after the
original date. A new meeting request should not be submitted. However, if a meeting is
canceled, the FDA will consider a subsequent request to schedule a meeting to be a new request
(i.e., a request that merits a new set of time frames as described in section VI., Assessing and
Responding to Meeting Requests). Requesters and the FDA should take reasonable steps to
avoid rescheduling and canceling meetings (unless the meeting is no longer necessary). For
example, if an attendee becomes unavailable, a substitute can be identified, or comments on the
10

See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022 available at
https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.

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478
479
480
481
482
483
484
485
486
487
488
489
490
491
492
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494
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500
501
502
503
504
505
506
507
508
509
510
511
512
513
514
515
516
517
518
519
520
521
522
523

topic that the attendee would have addressed can be forwarded to the requester following the
meeting. It will be at the discretion of the review division whether the meeting should be
rescheduled or canceled depending on the specific circumstances.
The following situations are examples of when a meeting can be rescheduled. Some of the
examples listed also represent reasons that a meeting may be canceled by the FDA. This list
includes representative examples and is not intended to be an exhaustive list.


The requester experiences a minor delay in submitting the meeting package. The
requester should contact the FDA project manager to explain why it cannot meet the time
frames for submission and when the meeting package will be submitted.



The review team determines that the meeting package is inadequate, or additional
information is needed to address the requester’s questions or other important issues for
discussion, but it is possible to identify the additional information needed and arrange for
its timely submission.



There is insufficient time to review the material because the meeting package is
voluminous (see section VII.C., Meeting Package Content), despite submission within the
specified time frames and the appropriateness of the content.



After the meeting package is submitted, the requester sends the FDA additional questions
or data that are intended for discussion at the meeting and require additional review time.



It is determined that attendance by additional FDA personnel not originally anticipated or
requested is critical and their unavailability precludes holding the meeting on the original
date.



Essential attendees are no longer available for the scheduled date and time because of an
unexpected or unavoidable conflict or an emergency situation.

The following situations are examples of when a meeting can be canceled:


The meeting package is not received by the FDA within the specified time frames (see
section VII.A., Timing of Meeting Package Submission) or is grossly inadequate.
Meetings are scheduled on the condition that appropriate information to support the
discussion will be submitted with sufficient time for review and preparatory discussion.
Adequate planning should avoid this problem.



The requester determines that preliminary responses to its questions are sufficient for its
needs and additional discussion is not necessary (see section VIII., Preliminary
Responses). In this case, the requester should contact the FDA project manager to
request cancellation of the meeting. The FDA will consider whether it agrees that the
meeting should be canceled. Some meetings, particularly milestone meetings, can be
valuable because of the broad discussion they generate and the opportunity for the
division to ask about relevant matters (e.g., dose-finding, breadth of subject exposure,

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525
526
527
528
529
530
531
532
533
534
535
536
537
538
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540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556
557
558
559
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561
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564
565

particular safety concerns), even if the preliminary responses seem sufficient to answer
the requester’s questions. If the FDA agrees that the meeting can be canceled, the reason
for cancellation will be documented and the preliminary responses will represent the final
responses and the official record.

X.

MEETING CONDUCT

Meetings will be chaired by an FDA staff member and begin with introductions and an overview
of the agenda. FDA policy prohibits audio or visual recording of discussions at meetings.
Presentations by requesters generally are not needed because the information necessary for
review and discussion should be part of the meeting package. If a requester plans to make a
presentation, the presentation should be discussed ahead of time with the FDA project manager
to determine if a presentation is warranted and to ensure that the FDA has the presentation
materials ahead of the meeting, if possible. All presentations should be kept brief to maximize
the time available for discussion. The length of the meeting will not be increased to
accommodate a presentation. If a presentation contains more than a small amount of content
distinct from clarifications or explanations of previous data and that were not included in the
original meeting package submitted for review, FDA staff may not be able to provide
commentary.
Either a representative of the FDA or the requester should summarize the important discussion
points, agreements, clarifications, and action items. Summation can be done at the end of the
meeting or after the discussion of each question. Generally, the requester will be asked to
present the summary to ensure that there is mutual understanding of meeting outcomes and
action items. FDA staff can add or further clarify any important points not covered in the
summary and these items can be added to the meeting minutes. At pre-NDA and pre-BLA
meetings for applications reviewed under the PDUFA Program for Enhanced Review
Transparency and Communication for NME NDAs and Original BLAs (also known as the
Program),11 the requester and the FDA should also summarize agreements regarding the content
of a complete application and any agreements reached on delayed submission of certain minor
application components.

XI.

MEETING MINUTES

Because the FDA’s minutes are the official records of meetings, the FDA’s documentation of
meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this
information is preserved for meeting attendees and future reference. The FDA will issue the
official, finalized minutes to the requester within 30 calendar days after the meeting.

11

See https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm.

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566
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569
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574
575
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578
579
580
581
582
583
584
585
586
587
588
589
590
591
592
593
594
595
596
597
598
599
600
601
602
603
604
605
606
607
608
609
610
611

The following are general considerations regarding meeting minutes:


FDA minutes will outline the important agreements, disagreements, issues for further
discussion, and action items from the meeting in bulleted format. This information does
not need to be in great detail. The minutes are not intended to represent a transcript of
the meeting.



FDA project managers will use established templates to ensure that all important meeting
information is captured.



The FDA may communicate additional information in the final minutes that was not
explicitly communicated during the meeting (e.g., pediatric requirements, data standards,
abuse liability potential) or that provides further explanation of discussion topics. The
FDA’s final minutes will distinguish this additional information from the discussion that
occurred during the meeting.

The following steps should be taken when there is a difference of understanding regarding the
minutes:


Requesters should contact the FDA project manager if there is a significant difference in
their and the FDA’s understanding of the content of the final meeting minutes issued to
the requesters



If after contacting the FDA project manager there are still significant differences in the
understanding of the content, the requester should submit a description of the specific
disagreements either:



‒

To the application; or

‒

If there is no application, in a letter to the division director, with a copy to the FDA
project manager

The review division and the office director, if the office director was present at the
meeting, will take the concerns under consideration
‒

If the minutes are deemed to accurately and sufficiently reflect the meeting
discussion, the FDA project manager will convey this decision to the requester and
the minutes will stand as the official documentation of the meeting.

‒

If the FDA deems it necessary, changes will be documented in an addendum to the
official minutes. The addendum will also document any remaining requester
objections, if any.

For input on additional issues that were not addressed at the meeting, the requester should submit
a new meeting request, a WRO request, or a submission containing specific questions for FDA
feedback.

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612
613
614
615
616
617
618
619
620
621
622
623
624
625
626
627
628
629
630
631
632
633
634

REFERENCES
Related Guidances12
Guidance for industry and review staff Best Practices for Communication Between IND
Sponsors and FDA During Drug Development
Guidance for review staff and industry Good Review Management Principles and Practices for
PDUFA Products
Related CDER MAPP13
MAPP 6025.6 Good Review Practice: Management of Breakthrough Therapy-Designated
Drugs and Biologics
Related CBER SOPPs14
SOPP 8101.1 Regulatory Meetings With Sponsors and Applicants for Drugs and Biological
Products
SOPP 8404.1 Procedures for Filing an Application When the Applicant Protests a Refusal to
File Action (File Over Protest)

12

Guidances can be found on the FDA Drugs guidance web page at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

13

MAPPs can be found on the Manual of Policies and Procedures web page at
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProc
edures/default.htm.

14

SOPPs can be found on the Biologics Procedures (SOPPs) web page at
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/defau
lt.htm.

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635
636
637
638
639
640

APPENDIX:
SUMMARY OF MEETING MANAGEMENT PROCEDURAL GOALS
Table A is a summary of Prescription Drug User Fee Act meeting management procedural goals.
Table A: Meeting Management Procedural Goals
Meeting FDA
FDA
FDA
Type
Response Receipt of Preliminary
to
Meeting
Responses to
Request
Package
Requester (if
applicable†)
A

B

641
642
643
644
645
646
647
648
649
650

14 days

21 days

B
(EOP)*

14 days

C

21 days

With
meeting
request
No later
than 30
days before
meeting
No later
than 50
days before
meeting**

No later than
2 days before
meeting
No later than
2 days before
meeting

No later
than 47
days before
meeting***

No later than
5 days before
meeting

No later than
5 days before
meeting

Requester
Response to
FDA
Preliminary
Responses (if
applicable†)
--

FDA
Scheduled
Meeting
Date (days
from receipt
of request)
Within 30
days

FDA
Meeting
Minutes to
Requester
(if
applicable†)
30 days after
meeting

--

Within 60
days

30 days after
meeting

Within 70
days

30 days after
meeting

Within 75
days

30 days after
meeting

No later than 3
days after
receipt of
preliminary
responses
No later than 3
days after
receipt of
preliminary
responses

†Not applicable to written response only.
* EOP = end of phase
** If the scheduled date of a Type B (EOP) meeting is earlier than 70 days from FDA receipt of the meeting request,
the requester’s meeting package will be due no sooner than 6 calendar days after FDA response time for issuing the
letter granting the meeting (see Table 1 in section VI.B., Meeting Granted).
*** If the scheduled date of a Type C meeting is earlier than 75 days from FDA receipt of the meeting request, the
meeting package will be due no sooner than 7 calendar days after FDA response time for issuing the letter granting
the meeting (see Table 1 in section VI.B., Meeting Granted). Note that for Type C meetings that are requested as
early consultations on the use of a new surrogate endpoint to be used as the primary basis for product approval in a
proposed context of use, the meeting package is due at the time of the meeting request.

17