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Guidance Documents/Guidance-Document/Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway

Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

January 7, 2025

January 6, 2025

Office of the Commissioner

ae83d008-58ac-4e99-bb05-ca1492236392

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