US FDA’s Approach to Biologics and ATMP Inspections
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…
Read More “US FDA’s Approach to Biologics and ATMP Inspections” »