https://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-assurance-cellular-and-gene-therapy-products
In saying that the above is “relevant”, I was being my understated self. The importance of the document is that it is another pointer towards an institutional awareness that there is something profound happening, waiting for its official endorsement as a gate-keeper and it’d better catch up fast with an updated framework for approval. Note how the document is dated 28 December 2023.
I think we are very close.
Ann: Update on Institutional Placement and Entitlement Offer, page-464
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