The Government Accountability Office says FDA should develop a policy on starting and ending enforcement discretion for unauthorized tests in future p...
Aurobindo reports receiving a six-item FDA 483 after an inspection at its Unit VII oral drug manufacturing unit in Jadcherla, Hyderabad, India.
FDA extends for 90 days the PDUFA review action dates for Amicus BLA and NDA for components of its AT-GAA, intended to treat late-onset Pompe disease....
Ropes & Gray attorneys see increasing cybersecurity expectations for medical device manufacturers in FDA regulations and congressional legislation.
Sanofi and AstraZeneca say additional Phase 3 and Phase 2b trial data continue to demonstrate nirsevimab efficacy against respiratory syncytial virus ...
FDA adds a surgical mask 510(k) review memo to its library of redacted memos for selected medical devices with a high volume of third-party reviews.
Federal Register notice: FDA denies a debarment hearing request from Marwan Massouh and issues an order debarring him for three years from providing ...
Federal Register notice: FDA renews its Gastrointestinal Drugs Advisory Committee for an additional two years.