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U.S. Department of Health and Human Services

Postmarket Requirements and Commitments

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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.

Center:       Both CBER and CDER  CBER   CDER   
NDA/ANDA/BLA Number:    
Requirement/Commitment Status:    

    Status Definitions

Required Under:     

  Accelerated Approval
  Animal Efficacy Rule
  Pediatric Research Equity Act
  FDAAA Section 505(o)(3)

NDA/ANDA/BLA Approval Date:    
  Date format:  mm/dd/yyyy
  From:    To:  



Downloadable Database File

FDA Home | Drugs Home | Vaccines, Blood & Biologics Home
PMC Coordinator: pmcweb@cder.fda.gov

FDA/Center for Drug Evaluation and Research
Office of New Drugs
Update Frequency: Quarterly
Database Last Updated: November 19, 2015