FDA publishes a guidance on its assessment of user fees under PDUFA 7.
Reps. Trahan and Crenshaw challenge FDAs ability to timely approve new preventive and therapeutic products to counter new Covid-19 variants.
Two major drug trade associations comment on an FDA draft guidance on external controls in drug and biologic clinical trials.
FDA clears a Nano-X Imaging 510(k) for its Nanox ARC, a stationary X-ray system intended to produce tomographic images of the human musculoskeletal sy...
FDA clears a Casana 510(k) for the Heart Seat, a smart toilet seat for measuring heart rate and oxygen saturation.
FDA publishes an International Council for Harmonization question-and-answer guidance on the M9 guidance on biopharmaceutics classification system-bas...
Federal Register notice: FDA announces a 6/8 Antimicrobial Drugs Advisory Committee meeting to discuss an AstraZeneca BLA for nirsevimab, a long-actin...
Federal Register notice: FDA sends to OMB an information collection extension entitled Current Good Manufacturing Practice in Manufacturing, Packaging...
