Two major drug trade associations comment on an FDA draft guidance on external controls in drug and biologic clinical trials.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...
Pharmaceutical Research and Manufacturers of America tells FDA artificial intelligence offers many opportunities for manufacturers and supports the ag...
Two SheppardMullin attorneys say that drug manufacturers seeking accelerated approval should be aware that 10% of drugs approved through the pathway u...
