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  5. Section 8000: General Information
  1. Biologics Procedures (SOPPs)

Section 8000: General Information

8001: Review

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: February 25, 2020

SOPP 8001.4: Review of Proprietary Names for CBER Regulated Products
Effective Date: December 13, 2023

SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)
Effective Date: January 12, 2023

SOPP 8004: Tissue Reference Group
Effective Date: February 27, 2023

SOPP 8005: Formal Dispute Resolution Process
Effective Date: February 27, 2023

SOPP 8006: Resolution of Differences in Scientific Judgement in the Review Process
Effective Date: January 15, 2009





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