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GUIDANCE DOCUMENT

Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 February 2006

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-1999-N-0098
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The purpose of this guidance is to assist applicants in meeting the requirements of section 130 of the Food and Drug Administration Modernization Act of 1997. This guidance provides recommendations on procedures, content, and format for submitting a postmarketing study commitment status report for an approved human drug or licensed biological product. This guidance also describes the FDA’s obligations to make certain information about postmarketing study commitments public, including the type of information that will be made public and the FDA’s time frames for reviewing postmarketing study commitment final reports.

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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-1999-N-0098.

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