Key Points from the FDA's Guidance for CAR T-Cell Products

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References

U.S. Food and Drug Administration. Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products: Draft Guidance for Industry. Posted March 2022. Accessed August 2022. https://www.fda.gov/media/156896/download.

U.S. Food and Drug Administration. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry. Posted January 2020. Accessed August 2022. https://www.fda.gov/media/113760/download.

https://www.regulations.gov/document/FDA-2021-D-0404-0001/comment.