A just-released Form FDA-483 shows that four months after a 10/2022 Warning Letter, the agency cited the firm again after an inspection documented sig...
FDA publishes a guidance on Quality System considerations and the content of premarket submissions relating to medical device cybersecurity.
FDA issues Botanix Pharmaceuticals a complete response letter on its NDA for sofpironium bromide gel, indicated for treating primary axillary hyperhid...
FDA posts a draft guidance with recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved m...
Reuters says its analysis of FDA regulatory actions shows an agency crackdown on companies that fail to sufficiently test cough syrups and other produ...
The Justice Department says a Florida man pleaded guilty to one count of conspiracy to introduce adulterated and misbranded HIV drugs into interstate ...
Federal Register notice: FDA announces an 11/30 public workshop entitled Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing ...
Vanda Pharmaceuticals asks the DC federal court to order FDA to vacate its corner-cutting approval of an MSN ANDA for a generic form of Vandas Hetlioz...
