Day: November 5, 2026

The landscape of cellular and gene therapy (CGT) manufacturing has shifted from isolated lot-release testing toward quality risk management. With the issuance of the FDA’s final guidance, Potency Assurance for Cellular and Gene Therapy Products, regulators have updated the 2011 release-testing framework to emphasize a lifecycle strategy. For regulatory affairs and CMC professionals, this document … Read more

Navigating the evolving landscape of combination product oversight requires regulatory strategy to be as dynamic as the technology itself. With the release of the updated FDA draft guidance on Essential Drug Delivery Device Performance Characteristics (EDDCs), regulatory professionals are presented with a refined framework designed to harmonize drug delivery performance with the Quality Management System … Read more