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North America

Canada

United States

United States

Agency Web SIte (TPD)

Priority review

Notice of Compliance with Conditions (NOC/c)

FRP Flow Chart

United States

United States

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

Project Orbis


FRP Flow Chart

Download North American FRP Details

CANADA - NOC.c FRP detail 5apr2020 (pdf)

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CANADA - Priority Review FRP detail 5apr2020 (pdf)

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USA - Accelerated Approval FRP detail 11apr2020 (pdf)

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USA FDA BTD detail 10aug19 (pdf)

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USA - CPP for Unapproved Product FRP detail13apr2020 (pdf)

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USA - Fast Track FRP detail 11apr2020 (pdf)

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USA - FDA RTOR FRP detail 13apr2020 (pdf)

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Project Orbis - FRP detail 19apr2020 (pdf)

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USA - Orphan Drugs FRP detail 12apr2020 (pdf)

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USA - Priority Review FRP detail 11apr2020 (pdf)

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USA - Regenerative Medicine Advanced Therapy FRP detail 12apr2020 (pdf)

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fphar liberti FDA FRP metromap 20171 (jpg)

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