Considerations for CAR T Cell Products

This document provides insight into FDA guidance for CAR-T therapies, but provided resources on assay design and suggestion. It discusses requirements for pre-INDs as well as suggestions for VCN and flow cytometry. This is for CAR-T, however, it most likely can be applied to similar models such as NK therapies.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-development-chimeric-antigen-receptor-car-t-cell-products