Federal Register notice: FDA announces the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study Data Tabulation Mode...
FDA issues SteadyMed Ltd. a Refuse-to-File letter on its NDA for Trevyent (treprostinil) for treating pulmonary arterial hypertension.
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...