FDA clears an Oryx Dental 510(k) for its imaging product, Oryx Imaging that allows health professionals to acquire, view, annotate, and organize denta...
FDA clears a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System for use in pedicle screw preparation and placement.
FDA publishes a guidance with principles and recommendations to ensure that critical elements of a products container label and carton labeling are de...
The House Energy and Commerce Committee unanimously votes (55 to 0) to advance the Food and Drug Amendments of 2022, bipartisan legislation that would...
FDA schedules its Science Board to the Food and Drug Administration Advisory Committee to consider challenges in evaluating the safety of dietary supp...
The Justice Department sues The Prometheus Group and its owner for allegedly recommending that single-use medical devices be used on multiple patients...
FDA warns Newbury Park, CA-based Colorful Products about CGMP violations in its manufacturing of over-the-counter topical drug products and hand sanit...
FDA warns Phoenix, AZ-based Specialty Process Labs about deviations from CGMP requirements for active pharmaceutical ingredients.