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University researchers say they found relatively few instances in which Oncology Drugs Advisory Committee members reported difficu...[ Price : $8.95]
CDER issues a white paper tracing the history of selective safety data collection (SSDC) and plans for the future.[ Price : $8.95]
FDA extends by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with rel...[ Price : $8.95]
Responding to congressional Democrats, the Congressional Budget Office says a nine-month increase in FDA drug review times would l...[ Price : $8.95]
FDA issues an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump.[ Price : $8.95]
FDA researchers analyze the results of good clinical practice inspections from 2017 to 2023, finding that less than 1% resulted in...[ Price : $8.95]
FDA warns Grand Ledge, MI-based O3UV about multiple CGMP violations in its illegal production of autohemotherapy devices.[ Price : $8.95]
FDA warns Indias Glenmark Pharmaceuticals about CGMP violations in the production of finished drugs at one of its manufacturing fa...