FDA commissioner Marty Makary says the agency is not planning to eliminate direct-to-consumer pharmaceutical advertising, even as it ramps up enforcem...
Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, especially for vulnerabl...
A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDAs regulatory framework under the Supreme Courts Loper Bright de...
FDA and CMS unveil a new joint initiative aimed at significantly shortening the time it takes for innovative medical devices to reach Medicare patient...
FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss.
FDA issues an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes included in medical conve...
FDA releases the form FDA-483 with five repeat observations from an inspection at Houston, TX-based Revive Rx Pharmacy.
FDA releases a form FDA-483 with six observations from an inspection at Indias Global Calcium active pharmaceutical ingredient manufacturing facility....
