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...
Two Ropes & Gray attorneys see signs that FDA may be shifting its approach to drug accelerated approvals.
FDA publishes a draft guidance with recommendations for 510(k) submissions for orthopedic non-spinal bone plate, screw, and washer devices.
