Postmarket Requirements and Commitments

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

FDA Home | Drugs Home | Vaccines, Blood & Biologics Home
PMC Coordinator:

FDA/Center for Drug Evaluation and Research
Office of New Drugs
Update Frequency: Quarterly
Database Last Updated: August 10, 2016

Page Last Updated: 08/09/2013
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