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Guidance Documents/Guidance-Document/How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry

How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

November 6, 2025

November 6, 2025

Office of the Commissioner

89fb560a-a61f-480a-9fe5-c7247ff0477d

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