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FDA publishes a draft guidance with recommendations on assessing the potency of monoclonal antibodies and some other therapeutic p...[ Price : $8.95]
CDER associate director for rare diseases Kerry Jo Lee marks Rare Disease Day 2023 by highlighting the new Accelerate Rare disease...[ Price : $8.95]
Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz describes early learnings from working with FDAs...[ Price : $8.95]
CBERs Office of Therapeutic Products announces a 4/27 public listening meeting to receive input on methods and approaches for capt...[ Price : $8.95]
An advisory committee votes to recommend that safety and effectiveness data were adequate to support approval of GSKs vaccine Arex...[ Price : $8.95]
An FDA letter to healthcare professionals warns about potential insufficient packaging sterility with a disposable part of the Get...[ Price : $8.95]
FDA sends Cytokinetics a complete response letter on its NDA for omecamtiv mecarbil, a cardiac myosin activator for treating heart...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of 11 ANDAs because the drug products are no longer marketed.