Federal Register notice: FDA sends to OMB an information collection revision entitled Prescription Drug Advertising.
A U.S. government amicus brief sides with the generic drug industry in a closely watched Supreme Court appeal of a skinny label case brought by GlaxoS...
Datascope recalls its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to an internal communication loss that could cause an unexpected shu...
Federal Register notice: FDA announces a 4/14 joint advisory committee meeting to discuss an Otsuka Pharmaceutical and Lundbeck supplemental NDA for R...
FDA says it is evaluating safety concerns with the use of some fixed palatal expander devices in adults to remodel the jaw or address conditions for w...
Midwest Veterinary Supply agrees to pay more than $10 million in forfeiture and fines as part of a plea agreement for misbranding prescription veterin...
FDA publishes a draft guidance recommending the information to be included in a predetermined change control plan in a marketing submission for a mach...
Reps. Buschon and DeGette reintroduce the bipartisan VALID Act to reform the regulation of diagnostic tests by FDA and the Centers for Medicare and Me...
