FAQ: Developing Potential Cellular & Gene Therapy Products

Guidance for Industry

Cell & Gene, FDA Guidelines

Draft FDA guidance intended to provide industry answers to FAQs and commonly faced issues that arise during the development of CGT products.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-developing-potential-cellular-and-gene-therapy-products

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U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research

Published June 2015

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