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Tag: pharmaceutical regulation

7 Feb
2026

Manufacturing Changes: Notification and Approval Requirements for Pharmaceutical Products

Manufacturing Changes: Notification and Approval Requirements for Pharmaceutical Products
  • Malcolm Oliver Kab
  • Medications
  • 0

Understand the FDA's three-tier system for manufacturing changes in pharmaceuticals: PAS, CBE-30, and annual reports. Learn how to classify changes, avoid violations, and stay compliant with global regulations.

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