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GUIDANCE DOCUMENT

Guidance for Industry Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act April 2011

Final Level 1 Guidance
Docket Number:
FDA-2009-D-0283
Issued by:
Guidance Issuing Office
Center for Drug 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 trials 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). This guidance provides information about the requirements for postmarketing studies and clinical trials under section 505(o)(3) of the Act. The guidance also describes the types of postmarketing studies and clinical trials that:

  • will generally be required under the new legislation (postmarketing requirements (PMRs)) and
  • will generally be agreed-upon commitments (postmarketing commitments (PMCs)) because they do not meet the new statutory criteria for required postmarketing studies and clinical trials.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

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.