FDA are certainly broadening their horizons in the Cell and Gene Therapy arena. Non Clinical assessment would most surely include data from EAP’s - just sayin’
“Nonclinical studies are an important part of medical product development and inform regulatory decisions.”
https://www.fda.gov/news-events/fda...sment-cell-and-gene-therapy-products-08302023
OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products
August 30, 2023
Focus for This Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products
Nonclinical studies are an important part of medical product development and inform regulatory decisions.
The data from nonclinical studies provide information on the safety and activity profile of an investigational product and guide the design of early-phase clinical trials. For more information, see the 2013 FDA guidance document for recommendations on the substance and scope of nonclinical information needed to support clinical trials for investigational cellular therapies, gene therapies, therapeutic vaccines, xenotransplantation, and certain biologic-device combination products.
Cell Therapy News/Articles, page-16403
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