A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDAs regulatory framework under the Supreme Courts Loper Bright de...
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....
Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, especially for vulnerabl...
FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss.
FDA commissioner Marty Makary says the agency is not planning to eliminate direct-to-consumer pharmaceutical advertising, even as it ramps up enforcem...
FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.
An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved applications before they...
