Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on, among other things, the design of bioeq...
FDA issues a Warning Letter to Total Thermal Imaging for illegally marketing and distributing an unapproved thermography device as a sole screening de...
Federal Register notice: FDA makes available a draft guidance entitled Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amput...
Federal Register notice: FDA reopens the comment period for an 11/15/2018 proposed rule on Institutional Review Board Waiver or Alteration of Informed...
FDA clears an Alphatec Holdings 510(k) for the SafeOp neuromonitoring system for use in real-time intraoperative nerve location and health assessments...
FDA posts two draft guidances to help drug developers with food effect studies and bioavailability studies.
FDA approves a Taiho Oncology NDA for Lonsurf (trifluridine and tipiracil) for treating adult patients with metastatic gastric or gastroesophageal jun...
FDA clears a Spirosure 510(k) for its Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma ...