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

Title:
FDA Guidance for Industry: How to Prepare a PreRequest for Designation (Pre-RFD)

https://www.gmp-compliance.org/files/guidemgr/how_to_prepare_a_pre-request_for_designation_pre-rfd_10-30-25.pdf

Origin/Publisher:

FDA

Content:
This guidance is intended to assist sponsors in obtaining a preliminary assessment from the U.S.Food and Drug Administration (FDA or Agency) through the Pre-Request for Designation (PreRFD) process.

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