The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA ...
The snacks were distributed in the state of New York and have been recalled due to undeclared additives and flavor enhancers.
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...
Scott Gottlieb and Luciana Borio, a former director for medical and biodefense preparedness policy at the National Security ...
Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...