Vaccines, Blood & Biologics
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Section 8000: General Information
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8001: Review
SOPP 8001.1: Interoffice Consultative Review Procedures
Effective Date: November 21, 1996SOPP 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, 2005SOPP 8001.4: Review of CBER Regulated Product Proprietary Names
Effective Date: November 24, 2008SOPP 8001.5: Intercenter Consultative/Collaborative Review Process
Effective Date: August 30, 2002SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMEA); Pilot
Effective Date: November 27, 2006- SOPP 8002: Procedures for the Preparation, Clearance and Issuance of Guidance Documents
Effective Date: December 10, 2012 SOPP 8003: Request For Designation
Effective Date: September 22, 1997SOPP 8004: Tissue Reference Group
Effective Date: May 3, 2013SOPP 8005: Major Dispute Resolution Process
Effective Date: February 11, 1999SOPP 8006: Resolution of Differences in Scientific Judgement in the Review Process
Effective Date: January 15, 2009SOPP 8007: DCC Binding Procedures for Regulatory Documents
Effective Date: November 13, 2009
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8008: Regulatory Information Systems
SOPP 8008.1: Administrative Handling of Change Requests for Regulatory Review Automated Support Systems
Effective Date: April 16, 2001SOPP 8010: Administrative Procedures for Emergency Use Authorization of Medical Products
Effective Date: August 3, 2005SOPP 8014: Procedures for the Preparation, Routing, and Issuance of Regulations
Effective Date: October 30, 2008
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