Attorney Michelle Yeary says a California state court granted Medtronic summary judgment on several product liability claims involving a spinal cord s...
FDA announces the retirement of CDER Office of Compliance director Don Ashley.
FDA principal deputy commissioner Janet Woodcock says the agency is exploring what flexibility it has in reviewing the science and health benefits of ...
Federal Register notice: FDA announces an Emergency Use Authorization for Abbott Molecular and its Alinity m MPXV monkeypox diagnostic test.
FDA makes available a draft guidance entitled Clostridioides difficile Infection (CDI): Developing Drugs for Treatment, Reduction of Recurrence, and P...
FDA officials list ways in which the agency is promoting the development of pediatric medicines.
FDA raises efficacy questions about a Y-mAbs BLA for I-omburtamab to treat pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.
The CDRH Digital Health Center of Excellence releases a document highlighting topics of interest for regulatory science research and partnerships.
