WebJan 17, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 312.42 Clinical holds and requests for modification. (a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. WebApr 29, 2024 · The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language. “We are grateful that the FDA has completed its review of the information we provided, and we are pleased that the clinical hold on our CP101 IND has been lifted,” …
FDA slaps hold on Finch
WebApr 28, 2024 · SOMERVILLE, Mass., April 28, 2024 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company ... helme online
U.S. FDA removes Clinical Hold on Finch’s investigational new …
WebApr 4, 2024 · The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language. “We are grateful that the FDA has completed its review of the information we provided, and we are pleased that the clinical hold on our CP101 IND has been lifted,” … WebApr 19, 2024 · The investigational new drug application for CP101 is on clinical hold while Finch awaits feedback from the FDA on the complete response letter that the company recently submitted related to its SARS-CoV-2 donor screening protocols and associated informed consent language. Finch is also developing FIN-211 for children with autism … WebMar 2, 2024 · In conjunction with the alert, regulators put Finch’s IND and then-manufacturer on partial hold so as to add Covid-19 testing to any donor material … helme mountainbike