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In this section: Biologics Procedures (SOPPs)

Section 8200: Investigational New Drugs (INDs)

SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications
Effective Date: December 15, 2023

SOPP 8203: Evaluation of Cost Recovery Requests for Investigational New Drugs and Investigational Device Exemptions
Effective Date: December 11, 2020

SOPP 8212: Breakthrough Therapy Products - Designation and Management
Effective Date: August 1, 2023

SOPP 8215: Management of Regenerative Medicine Advanced Therapy Products: Request for Designation, Sponsor Interactions, and Status Assessment
Effective Date: September 14, 2023

SOPP 8216: Fast Track Development Programs - Designation and Management
Effective Date: February 27, 2023

SOPP 8217: Administrative Processing and Review Management Procedures for Investigational New Drug Applications
Effective Date: July 5, 2024

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