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: May 8, 2007
• SOPP 8107: Official Correspondence with Applicants of Marketing Submissions: Addresses 
  Effective Date: April 16, 2001
• SOPP 8108: Distribution of "Dear Doctor" Letters 
  Effective Date: June 7, 2002
• SOPP 8110: Submission of Regulatory Documents to CBER 
  Effective Date: February 6, 2003
• 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: July 15, 2009
• 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