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FDA publishes a draft guidance recommending the information to be included in a predetermined change control plan in a marketing submission for a mach...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FDA publishes a draft guidance to assist in understanding the processes used for the review of some research involving children as subjects that is no...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.
FDA approves an Abbott PMA supplement for Epic Max, a stented tissue valve to treat people with aortic regurgitation or stenosis.
FDA converts Mercks Keytruda immunotherapy from accelerated to full approval for treating certain solid tumors
FDA commissioner Robert Califf tells House appropriators that reported plans on budget cuts of up to 22% being floated by Republican lawmakers would h...
