Today, DHC's Amanda Mack and Alicja Fiedorowicz published their article addressing "FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies" on Life Science Connect's cellandgene.com
"In April 2024, the U.S. FDA released the draft guidance titled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.1 The guidance aims to supplement existing FDA guidance documents to assist sponsors of such products in meeting regulatory requirements set out in 21 CFR 610.18(c)(1) and 312.23(a)(7) to de-risk safety concerns within their IND or biologics license application (BLA).2,3,4,5 By integrating with these established guidelines, the new guidance will provide an updated regulatory framework with intention to cover safety testing of a broader spectrum of cell-based products, reduce redundancy, and ensure comprehensive oversight. The FDA is actively seeking comments until July 29, 2024, to further strengthen and inform this draft guidance."
In this article, we...
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