US FDA’s Approach to Biologics and ATMP Inspections

digi — Fri, 06 Jun 2025 15:23:19 +0000

US FDA’s Approach to Biologics and ATMP Inspections How the FDA Inspects Biologics and Advanced Therapy Medicinal Products (ATMPs) The inspection of biologics and Advanced Therapy Medicinal Products (ATMPs) such as gene therapies, cell therapies, and tissue-engineered products requires a unique regulatory lens. The US Food and Drug Administration (FDA) applies a specialized inspectional approach...

FDA ATMP site audit – Pharma GMP

US FDA’s Approach to Biologics and ATMP Inspections