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,” … WebMar 22, 2024 · A clinical hold is an order that FDA issues to a sponsor to delay a proposed investigation or to suspend an ongoing investigation. When a proposed study is placed on clinical hold, subjects may ...
Finch Therapeutics Announces Removal of FDA Clinical Hold on …
WebApr 29, 2024 · The FDA has lifted a clinical hold on the biotech’s donor-derived microbiome drug for Clostridioides difficile, clearing the way for a phase 3 study to proceed—eventually. WebMay 16, 2024 · FDA Removed Clinical Hold on CP101 IND: In April 2024, Finch announced that the U.S. Food and Drug Administration (FDA) removed the clinical hold on its investigational new drug (IND) application for CP101 following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated … gulfeagle supply las vegas
Finch Therapeutics Provides Corporate Update and Reports
WebMar 1, 2024 · In January 2024, Finch's then-contract manufacturer, OpenBiome, was released from clinical hold after implementing a direct testing method for SARS-CoV-2 provided by a third-party vendor. WebApr 28, 2024 · Finch anticipates to proceed with enrollment in PRISM4 after it completes certain manufacturing activities and quality updates regarding the clinical hold and push the details to FDA for review. WebApr 28, 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,” … gulf eagle supply ludington mi