FDA 5023 Right-to-Try Annual Reporting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

RIGHT TO TRY REPORTING REQUIREMENT:
ANNUAL SUMMARY

Form Approved:
OMB No. 0910-0893
Expiration Date:
Month XX, 20XX

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. The OMB control number for this collection of information is 0910-0893 and it expires xx/xx/xxxx. The time burden for this collection
of information is estimated to average 2.5 hours per response, including the time to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the information to FDA.
Calendar Year Reporting Period

Submitter Name

Submitter Email Address

Name of Manufacturer or Sponsor

Eligible
IND Number¹ Number of Number of
Investigational
Doses
Patients
Drug¹
Supplied²
Treated³

Disease(s) or
Condition(s)⁴

Serious Adverse Event(s)⁵

SAE(s)
EXAMPLE:
XDX501

EXAMPLE:
9999999

EXAMPLE: EXAMPLE:
5
1

EXAMPLE:
Breast cancer

Outcome(s)

EXAMPLE:
EXAMPLE:
1. Hip fracture 1. Improved
2. Joint pain 2. Improved

OPTIONAL: Additional contextual information (e.g., time between dose received and onset of serious adverse event)

(Footnotes)
¹ The name and IND number of the eligible investigational drug supplied by the manufacturer or sponsor for use under section 561B of the Federal
Food, Drug, and Cosmetic Act.
² The total number of doses supplied by the manufacturer or sponsor to eligible patients for use under section 561B of the Federal Food, Drug, and
Cosmetic Act. Each dose of an eligible investigational drug supplied for an eligible patient shall be counted as a dose supplied.
³ The total number of eligible patients for whom the manufacturer or sponsor provided the eligible investigational drug for use under section 561B of
the Federal Food, Drug, and Cosmetic Act. An eligible patient treated more than one time or with multiple doses of an eligible investigational drug
shall be counted as a single patient.
⁴ The disease or conditions for which the eligible investigational drug was made available for use under section 561B of the Federal Food, Drug,
and Cosmetic Act.
⁵ Any known serious adverse events, including resulting outcomes, experienced by patients treated with the eligible investigational drug under
section 561B of the Federal Food, Drug, and Cosmetic Act.

FORM FDA 5023 (10/22)

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