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Federal Register notice: FDA makes available a draft guidance entitled Research Involving Children as Subjects and Not Otherwise Approvable by an IRB:...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FDA publishes a draft guidance recommending the information to be included in a predetermined change control plan in a marketing submission for a mach...
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...
FDA publishes a draft guidance to assist in understanding the processes used for the review of some research involving children as subjects that is no...
CBER director Peter Marks says hed like to see aligned global regulations to boost commercialization for gene and cell therapies.
