-
Vaccines, Blood & Biologics
-
Section 8000: General Information
-
8001: Review
- SOPP 8001.1: Interoffice Consultative Review Procedures
Effective Date: November 21, 1996 - SOPP 8001.2: Accessing the FDA Lists of Disqualified and Restricted Clinical Investigators, Debarred Individuals, and Firms Under the FDA Application Integrity Policy
Effective Date: April 8, 2005 - SOPP 8001.4: Review of CBER Regulated Product Proprietary Names
Effective Date: November 24, 2008 - SOPP 8001.5: Intercenter Consultative/Collaborative Review Process
Effective Date: August 30, 2002 - SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMEA); Pilot
Effective Date: November 27, 2006 - SOPP 8002: Procedures for the Preparation, Routing and Issuance of Guidance Documents
Effective Date: Date: September 21, 2009 - SOPP 8003: Request For Designation
Effective Date: September 22, 1997 - SOPP 8004: Tissue Reference Group
Effective Date: June 7, 2002 - SOPP 8005: Major Dispute Resolution Process
Effective Date: February 11, 1999 - SOPP 8006: Resolution of Differences in Scientific Judgement in the Review Process
Effective Date: January 15, 2009 - SOPP 8007: DCC Binding Procedures for Regulatory Documents
Effective Date: November 13, 2009
-
-
8008: Regulatory Information Systems
- SOPP 8008.1: Administrative Handling of Change Requests for Regulatory Review Automated Support Systems
Effective Date: April 16, 2001 - SOPP 8010: Administrative Procedures for Emergency Use Authorization of Medical Products
Effective Date: August 3, 2005 - SOPP 8014: Procedures for the Preparation, Routing, and Issuance of Regulations
Effective Date: October 30, 2008
-
-
-