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.
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.
Ongoing Pending Delayed Terminated Submitted Fulfilled Released All Statuses Status Definitions
Accelerated Approval Animal Efficacy Rule Pediatric Research Equity Act FDAAA Section 505(o)(3)
Downloadable Database File
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