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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

Final Level 1 Guidance

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

Issued by:
Guidance Issuing Office
Center for Drug 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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.