Datascope recalls its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to an internal communication loss that could cause an unexpected shu...
FDA issues a 14-page Form FDA-483 to Global Pharma Healthcare in Tamilnadu, India that cites significant GMP deficiencies with its drug manufacturing.
Senators Tina Smith (D-MN) and Mike Braun (R-IN) reintroduce bipartisan legislation that would prevent brand drug companies from seeking agreements wi...
Hutchmed Ltd. completes a rolling NDA submission for fruquintinib, described as a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3 for...
Federal Register notice: FDA makes available a draft guidance entitled Research Involving Children as Subjects and Not Otherwise Approvable by an IRB:...
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FDA publishes a draft guidance recommending the information to be included in a predetermined change control plan in a marketing submission for a mach...
