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  1. Biologics Post-Market Activities

Postmarketing study commitments are studies required of or agreed to by a sponsor that are conducted after FDA has approved a product for marketing. FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. Agreements with sponsors to conduct postmarketing studies can be reached either before or after FDA has granted approval to a sponsor to market a product.

The Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Food, Drug and Cosmetic Act by adding a new section 506B (21 U.S.C. 356b). This section provides additional authority for monitoring the progress of postmarketing studies that drug and biologic applicants have agreed to conduct. Congress enacted this section in response to concerns expressed by the Food and Drug Administration and the public about the timeliness of completing postmarketing studies and about the need to update drug labeling with information obtained from such studies.

This provision requires sponsors of approved drugs and biologics to report to FDA annually on the progress of their postmarketing study commitments.

In addition, FDA must publish annually in the Federal Register a report that provides information on the status of postmarketing studies that sponsors have agreed to conduct and for which annual reports have been submitted.

FDA also agreed to make basic information about the status of each postmarketing study commitment available to the public on the Internet.

The postmarketing study information includes the basic information the FDA committed to make available to the public. Proprietary information is not included.

The list will be updated quarterly (in April, July, October, and January). New commitments and status updates for existing commitments will be added to the list with the updates.

Questions or comments may be sent to the Postmarketing Study Commitment Coordinator at pmcweb@cder.fda.gov.

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