FDA To Issue Wave Of Guidance To Advance Cell and Gene Therapies

By David Roza / January 15, 2019 at 7:39 PM
FDA officials announced a batch of upcoming guidance documents and agency actions they say will help steer a surge of new cell and gene therapy products currently being developed. The agency is planning to issue myriad guidances, which will outline accelerated approval pathways for sponsors; provide recommendations on developing products to treat inherited blood disorders and neurodegenerative diseases; lay out parameters for using new technologies in manufacturing; and set forth a new trial design by which certain sponsors seeking biologics...


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