Section 8200: Investigational New Drugs (INDs)
SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications
Effective Date: June 15, 2022
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: February 27, 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: February 27, 2023