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Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance for Industry

Issue Date: October 25, 2019
Issued by: Center for Biologics Evaluation and Research
Topic(s): Safety – Issues, Errors, and Problems
Status: Draft

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Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance for Industry

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).

Download the Guidance Document