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...
FDA joins with the Lupus Research Alliance to launch a collaborative Lupus Accelerated Breakthrough Consortium to improve lupus clinical trial success...
FDA approves Emergent BioSolutions Narcan 4 mg naloxone hydrochloride nasal spray, the first nonprescription over-the-counter product for reversing th...
Janssen Pharmaceutical discontinues the development of an investigational respiratory syncytial virus adult vaccine and related Phase 3 study due to b...
Federal Register notice: FDA sends to OMB an information collection extension entitled Testing Communications by FDAs Center for Devices and Radiologi...
