FDA commissioner Robert Califf tells House appropriators that reported plans on budget cuts of up to 22% being floated by Republican lawmakers would h...
FDA lifts its partial clinical hold against Vigil Neuroscience and doses greater than 20 mg/kg for VGL101 in clinical trials in certain patients with ...
Federal Register notice: FDA announces a 5/9 Advisory Committee meeting to discuss a non-RX birth control pill.
Federal Register notice: FDA announces a 5/11 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss an ARS Pharmaceuticals NDA for epinephrine...
Federal Register notice: FDA announces a 4/14 joint advisory committee meeting to discuss an Otsuka Pharmaceutical and Lundbeck supplemental NDA for R...
An FDA guidance says the agency will start to refuse to accept cyber device premarket submissions that dont contain required cyber security informatio...
FDA warns Washington University pediatrics researcher Robert Hayashi about objectionable conditions in his conduct of two clinical investigations.
Gardner Law attorney Jesse Atkins suggests ways for medical device developers and manufacturers to keep up with rapidly changing FDA regulatory oversi...
