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  4. Biologics Procedures (SOPPs)
  5. Section 8500: Compliance
  1. Guidance, Compliance & Regulatory Information (Biologics)

Section 8500: Compliance

SOPP 8503.2: Review of Import for Export Requests Under F D & C Act Section 801(d)(4)
Removed for Revision: September 1, 2009

8503: Import and Export Requests

SOPP 8504: Release of Establishment Inspection Reports to the Inspected Establishments Pursuant to Field Management Directive 145
Effective Date: March 19, 2019

SOPP 8506: Management of Shortages of CBER-Regulated Products
Effective Date: September 7, 2018

SOPP 8507: Procedures for Responding to an Illegitimate Product Notification and Request for Termination of Notification
Effective Date: January 27, 2016

SOPP 8508: Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Effective Date: March 26, 2008

SOPP 8508.2: Procedures for the Vaccine Safety Team
Effective Date: May 9, 2008

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