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CDRH officials say the Centers early feasibility study program is benefitting sponsors, FDA, and the public.[ Price : $8.95]
CDER director Janet Woodcock says the agency is more closely monitoring the safety of PD-1/PD-L1 inhibitors after an investigation...[ Price : $8.95]
Charleston Laboratories says it will resubmit the NDA for its CL-108 pain management drug after ending a collaboration with Daiich...[ Price : $8.95]
Sunovion Pharmaceuticals files an NDA for dasotraline, an investigational, dual-acting dopamine and norepinephrine reuptake inhibi...[ Price : $8.95]
FDA commissioner Scott Gottlieb says a new concept of operations for CDER and ORA is being implemented to integrate drug facility ...[ Price : $8.95]
Hospira recalls one lot of vancomycin hydrochloride after confirming a report of glass particulate in one vial in the lot.[ Price : $8.95]
Federal Register notice: FDA announces support for the most current version of the Medical Dictionary for Regulatory Activities, a...[ Price : $8.95]
Federal Register notice: FDA determines that Tevas Cenestin (estrogens, conjugated synthetic A) tablets, 0.3 milligrams (mg), 0.45...