FDA publishes a finalized guidance on Medical Devices Advisory Committee panel meetings.
CDRH officials say the Centers early feasibility study program is benefitting sponsors, FDA, and the public.
CDER director Janet Woodcock says the agency is more closely monitoring the safety of PD-1/PD-L1 inhibitors after an investigational clinical trial in...
Charleston Laboratories says it will resubmit the NDA for its CL-108 pain management drug after ending a collaboration with Daiichi Sankyo.
Sunovion Pharmaceuticals files an NDA for dasotraline, an investigational, dual-acting dopamine and norepinephrine reuptake inhibitor for treating chi...
FDA commissioner Scott Gottlieb says a new concept of operations for CDER and ORA is being implemented to integrate drug facility inspections and prod...
Hospira recalls one lot of vancomycin hydrochloride after confirming a report of glass particulate in one vial in the lot.
Federal Register notice: FDA announces support for the most current version of the Medical Dictionary for Regulatory Activities, and it ends support f...