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In this section: Biologics Procedures (SOPPs)

Section 8100: Communication

8101: Meetings

SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
Effective Date: July 17, 2024

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: February 27, 2023

SOPP 8119: Use of Email for Regulatory Communications
Effective Date: April 9, 2024

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