North America

Canada

Agency Web SIte (TPD)

FRP Detail Summary

FRP Flow Chart

United States

Agency Web SIte (USFDA)


FDA Accelerated Approval FRP Detail Summary

FDA Breakthrough Therapy

FDA CPP for Unapproved Products

FDA Fast Track

FDA Orphan Designation

FDA Priority Review

FDA Real Time Oncology Review (RTOR)

FDA Regenerative Medicine Advanced Therapy Designation


FRP Flow Chart

Download North American FRP Details

FRP detail FDA BTD v10aug19 (pdf)

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