FDA Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products (Catapult's regulatory round-up - May 2024)

FDA has issued a draft guidance which provides recommendations regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of cellular and gene therapy (CGT) and tissue-engineered products (TEP). This guidance applies to reagents, feeder cells and excipients and other inactive ingredients in the drug product that are in direct contact with the starting material, intermediates, final products, and any materials used to manufacture reage...