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FDA publishes a guidance on Quality System considerations and the content of premarket submissions relating to medical device cybe...[ Price : $8.95]
FDA issues Botanix Pharmaceuticals a complete response letter on its NDA for sofpironium bromide gel, indicated for treating prima...[ Price : $8.95]
FDA posts a draft guidance with recommendations on how animal drug sponsors may voluntarily establish a defined duration of use fo...[ Price : $8.95]
Reuters says its analysis of FDA regulatory actions shows an agency crackdown on companies that fail to sufficiently test cough sy...[ Price : $8.95]
The Justice Department says a Florida man pleaded guilty to one count of conspiracy to introduce adulterated and misbranded HIV dr...[ Price : $8.95]
Federal Register notice: FDA announces an 11/30 public workshop entitled Advancing the Development of Pediatric Therapeutics (ADEP...[ Price : $8.95]
Vanda Pharmaceuticals asks the DC federal court to order FDA to vacate its corner-cutting approval of an MSN ANDA for a generic fo...[ Price : $8.95]
Attorney Maarika Kimbrell discusses the challenges facing CBER as it reorganizes to meet PDUFA 7 commitments and an increase in IN...