Docket Number:
FDA-2009-D-0283
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

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).

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All written comments should be identified with this document's docket number: FDA-2009-D-0283.