SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications
Effective Date: December 11, 2020

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

SOPP 8206: Discontinuing Investigational and Related Applications (IRAs)
Effective Date: March 12, 2008

SOPP 8212: Management of Breakthrough Therapy-Designated Products: Sponsor Interactions and Status Assessment Including Rescinding
Effective Date: February 3, 2022

SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products
Effective Date: December 11, 2020