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GUIDANCE DOCUMENT

Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act March 2011

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

This guidance provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(o)), added by section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 505(o)(3) authorizes FDA to require certain postmarketing studies and clinical trials2 for prescription drugs approved under section 505 of the Act and biological products approved under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262).3 This guidance provides information about the requirements for postmarketing studies and clinical trials under section 505(o)(3) of the Act.


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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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