8101: Meetings

• SOPP 8101.1: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants Effective Date: May 18, 2007
• SOPP 8101.2: Scheduling and Documentation of Liaison Meetings Effective Date: November 17, 2000
• SOPP 8101.3: Participation in or Planning of Outside Regulatory and Scientific Events Effective Date: August 3, 2005
• SOPP 8103: Headquarters Contacts With Regulated Manufacturers During Agency Inspections Effective Date: April 9, 1999
• SOPP 8104: Documentation of Telephone Contacts with Regulated Industry Effective Date: August 3, 2010
• SOPP 8107: Official Correspondence with Applicants of Marketing Submissions: Addresses Effective Date: April 16, 2001
• SOPP 8110: Submission of Paper Regulatory Applications to CBER Effective Date: June 3, 2010
• SOPP 8113: Handling of Regulatory Faxes Effective Date: October 15, 2007
• SOPP 8114: Administrative Processing of Documents Received Prior to Submitting Investigational or Marketing Applications (Pre-Application) Effective Date: April 16, 2007
• SOPP 8115: Regulatory Site Visit Training Program Effective Date: November 22, 2005
• SOPP 8116: Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff Effective Date: April 23, 2012
• SOPP 8117: Issuing Submission Numbers in Advance of the Receipt of the Electronic Submission Effective Date: September 24, 2007
• SOPP 8119: Use of Email for Regulatory Communications Effective Date: February 13, 2009