Biologics Procedures (SOPPs)

8101: Meetings SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products Effective Date: December 11, 2025 SOPP 8101.2: Scheduling and Documentation of Liaison Meetings With Industry Trade Organizations Effective Date: April 15, 2024 SOPP 8101.3: Participation in or Planning of Outside Regulatory and Scientific Events Effective Date: November 27, 2019 SOPP 8103: Headquarters Contacts with Regulated Manufacturers during Agency Inspections Effective Date: July 31, 2022 SOPP 8104: Documentation of Telephone Contacts with Regulated Industry Effective Date: December 11, 2020 SOPP 8110: Submission of Regulatory Applications -- Exempt from eCTD Requirements Effective Date: August 23, 2020 SOPP 8113: Handling of Regulatory Faxes in CBER Effective Date: December 11, 2020 SOPP 8114: Administrative Processing of Documents Received Prior to Submitting Investigational or Marketing Applications (Pre-Application) Effective Date: December 11, 2020 SOPP 8116: Use of Electronic Signatures for Regulatory Documents Effective Date: December 11, 2020 SOPP 8117: Issuing Tracking Numbers in Advance of Electronic Submissions in eCTD Format Effective Date: October 30, 2025