Postmarketing commitment studies 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. A separate Web site is available for post approval studies for medical devices.
NDA/ANDA/BLA Number:
Ongoing Pending Delayed Terminated Submitted Fulfilled Released All Statuses Commitment Status Definitions
Accelerated Approval Animal Efficacy Rule Pediatric Research Equity Act
Downloadable Database File
FDA Home | CDER Home | CBER Home PMC Coordinator: pmcweb@cder.fda.gov
