FDA publishes a draft guidance with recommendations on assessing the potency of monoclonal antibodies and some other therapeutic proteins.
CDER associate director for rare diseases Kerry Jo Lee marks Rare Disease Day 2023 by highlighting the new Accelerate Rare disease Cures program.
Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz describes early learnings from working with FDAs new eSTAR 510(k) su...
CBERs Office of Therapeutic Products announces a 4/27 public listening meeting to receive input on methods and approaches for capturing post-approval ...
An advisory committee votes to recommend that safety and effectiveness data were adequate to support approval of GSKs vaccine Arexvy for preventing lo...
An FDA letter to healthcare professionals warns about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohe...
FDA sends Cytokinetics a complete response letter on its NDA for omecamtiv mecarbil, a cardiac myosin activator for treating heart failure with reduce...
Federal Register notice: FDA withdraws approval of 11 ANDAs because the drug products are no longer marketed.
