OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
FDA clears Outset Medical of previous warning issues
Inc. (NASDAQ:OM), a medical technology company focused on innovating dialysis treatment, has resolved all concerns raised in a Warning Letter from the U.S. Food and Drug Administration (FDA) dating ...
JD Supra1d
A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in ...
JD Supra4d
FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications
FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...