Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance for Industry | Guideline Explorer

Description

This guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(o)(3)), which authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs approved under section 505(c) of the FD&C Act and biological products approved under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262).

Scope & Applicability

Product Classes

4

Prescription Drug

Early-phase randomized, double-blind, parallel assignment clinical study

Gene Therapy

A type of ATMP involving recombinant nucleic acids or viral vectors.

Biological Product

Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition

Controlled Substance

Drugs subject to the Controlled Substances Act requiring schedule display

Stakeholders

3

Applicant

Entity submitting development data and knowledge; Entity performing the work process for change

Responsible person

The individual at an HCT/P establishment who must determine and document donor eligibility.

Data Partners

Participants in the Sentinel system who transform local data

Regulatory Context

Attributes

1

New Safety Information

Information that triggers the authority to require PMRs

Identified Hazards

Hazards

5

Serious Risk

Associated with the use of a drug that FDA becomes aware of post-approval

Unexpected serious risk

Serious adverse drug experience not listed in the labeling

Cross contamination

risk to be avoided through physical barriers and sanitation

Reproductive toxicology

Risk to reproductive health assessed in animal studies

Carcinogenic potential

Risk of causing cancer assessed in animal studies

Related CFR Sections (7)

21CFR601.91§ 601.91 Approval based on evidence of effectiveness from studies in animals.
(a) FDA may grant marketing approval for a biological product for which safety has been established and for which the requirements of § 601.90 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the biological product is reasonably likRead full regulation →
21CFR314.610§ 314.610 Approval based on evidence of effectiveness from studies in animals.
(a) FDA may grant marketing approval for a new drug product for which safety has been established and for which the requirements of § 314.600 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the drug product is reasonably likely to Read full regulation →
21CFR312.3§ 312.3 Definitions and interpretations.
(a) The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:Read full regulation →
21CFR601.41§ 601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
FDA may grant marketing approval for a biological product on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, tRead full regulation →
21CFR314.510§ 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predicRead full regulation →
21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
21CFR601.70§ 601.70 Annual progress reports of postmarketing studies.
(a) General requirements. This section applies to all required postmarketing studies (e.g., accelerated approval clinical benefit studies, pediatric studies) and postmarketing studies that an applicant has committed, in writing, to conduct either at the time of approval of an application or a suppleRead full regulation →

Related Warning Letters (10)

In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
2025-12-23
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
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2025-12-09
Sponsor/Investigator
Verdure Sciences, Inc.
2025-11-18
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
2025-09-30
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
2025-09-23
False & Misleading Claims/Misbranded
Novo Nordisk Inc.
2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
2025-09-16
Clinical Investigator
Shirish M. Gadgeel, M.D.
2025-09-09
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
2025-08-26