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# CAR T Cell Product Development Guidance
- URL: https://www.fdaweb.com/car-t-cell-product-development-guidance/
- Published: 2022-03-15T12:00:00.000Z
- Updated: 2026-09-14T17:36:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151368

FDA has published a draft guidance, *Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products*, to assist industry and academic sponsors in developing such products. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-development-chimeric-antigen-receptor-car-t-cell-products?ref=fdaweb.com) provides CAR T cell-specific recommendations about chemistry, manufacturing, and control; pharmacology and toxicology; and clinical study design.

Recommendations specific to autologous or allogeneic CAR T cell products are noted in the guidance. It also provides recommendations for analytical comparability studies for CAR T products.

FDA says that while the guidance specifically focuses on CAR T cell products, much of its information and recommendations will also apply to other genetically modified lymphocyte products such as CAR Natural Killer cells or T cell receptor-modified T cells.

Included in the guidance are Introduction, Background, General Considerations for CAR T cell design and development, CMC Recommendations, Preclinical Recommendations, Clinical Recommendations, and References.