Request that the FDA amend 21 C.F.R. § 1271.10(a) to provide that stem cell products shall be regulated solely under section 361 of the Public Health Service Act and 21 C.F.R. Part 1271 (i.e., as 361 HCTPs) provided that the stem cell products and their production facilities comply with the current good manufacturing practices and certain production facility
🏛 Food and Drug Administration (FDA)FDA-2025-P-6021
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