Yesterday (30 April 2024), the FDA released a draft guidance for the industry titled "Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products" and on 29th April, 2024 released final guidance "Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels".
Guidance: Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products
Cell and Gene Therapy (CGT) and Tissue-Engineered Medical Products (TEMP): These are products that contain or consist of human cells, tissues, or cellular or tissue-based products that are intended for implantation, transplantation, infusion, or transfer into a human recipient.
Human-Derived Materials: These are materials derived from human sources, such as cells, tissues, or biological fluids.
Animal-Derived Materials: These are materials derived from animal sources, such as cells, tissues, or biological fluids.
With this guidance, manufacturers of CGT and TEMP products are given recommendations about assuring the safety, quality, and identity of materials of human and animal origin used in their manufacture. In addition, recommendations are made regarding the chemistry, manufacturing, and control (CMC) information submitted in an investigational new drug application (IND) regarding the use of human-derived and animal-derived materials. CGT products and TEMPs that are manufactured using human- and animal-derived materials. These considerations include donor screening and testing, adventitious agent testing and screening, risk assessment, and materials management.
Blood and Blood Components: These are products derived from blood, such as red blood cells, platelets, plasma, and cryoprecipitate.
Standard Container Labels: These are labels that conform to a recognized standard for the identification and labeling of blood and blood components.
This guidance is crucial for ensuring the safety and proper identification of blood and blood components throughout the supply chain. It provides an overview of the guidance and its purpose in establishing uniform standards for blood and blood component container labels. FDA believes that this uniform container label standard will assist manufacturers in complying with the container label requirements under Title 21 of the Code of Federal Regulations 606.121 (21 CFR 606.121).