Postmarket Requirements and Commitments

Introduction |  FAQ

Postmarket requirement and commitment studies and clinical trials occur after a drug or biological product has been approved by FDA.  For more information, please read: "Report to Congress: Reports on Postmarketing Studies [FDAMA 130]" and the Guidance for Industry (PDF - 456KB). A separate Web site is available for post approval studies for medical devices.

Downloadable Database File

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PMC Coordinator: pmcweb@cder.fda.gov