FDA adds 171 devices to its list of AI/ML-enabled medical devices.
FDA cautions Indias Nectar Lifesciences about CGMP violations in its production of finished drugs.
The FDA Oncology Center of Excellence explains its OCE Scientific Collaborative regulatory research support efforts focused on nine interest areas and...
FDA clears a Cardio Flow510(k) for the companys FreedomFlow Orbital Atherectomy Peripheral Platform.
Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support P...
Federal Register notice: FDA withdraws two guidances Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C ...
FDA warns Denver, CO-based Hygienic Labs that it has not responded to multiple requests for records and information so the agency can assess the quali...
Bristol Myers Squibb says it will seek approval for a subcutaneous formulation of its Opdivo (nivolumab) for use in patients with advanced or metastat...
