8101: Meetings

SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
Effective Date: December 11, 2020

SOPP 8101.2: Scheduling and Documentation of Liaison Meetings With Industry Trade Organizations
Effective Date: January 9, 2020

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: December 11, 2020

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 8115: Regulatory Site Visit Training Program
Effective Date: November 22, 2005

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: December 11, 2020

SOPP 8119: Use of Email for Regulatory Communications
Effective Date: January 22, 2021