FDA stands to gain a $663 million (13%) budget boost in President Trumps just-released fiscal year 2019 budget proposal.
FDA adds new information to the labeling of warfarin international normalized ratio test meters based on adverse events.
FDA approves a Vertex Pharmaceuticals NDA for Symdeko (tezacaftor/ivacaftor) for treating the underlying cause of cystic fibrosis in certain patients ...
FDA commissioner Scott Gottlieb gets mostly high marks from agency watchers, according to a New York Times article.
FDA posts a guidance on Bacillus Calmette-Gurin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.
Federal Register notice: FDA submits for OMB approval an information collection extension request for Content and Format of Labeling for Human Prescri...
Federal Register notice: CDER announces a continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program.
FDA Review posts the Federal Register notices for the week ending 2/9/2018.