FDA posts a guidance on Pediatric Information for X-ray Imaging Device Premarket Notifications that outlines the agencys current thinking of on inform...
A former compliance director at Indiana compounding pharmacy Pharmakon Pharmaceuticals pleads guilty to introducing adulterated drugs into interstate ...
FDA Review posts product approval summaries for the week ending 11/24/2017.
FDA Review posts the latest FDA Federal Register notices for the week ending 11/24/2017.
Federal Register notice: FDA makes available a guidance entitled General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid D...
Federal Register notice: FDA announces a 1/9/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting in Hyattsville, MD that will review...
Federal Register notice: FDA announces a 2/7-8/2018 public workshop entitled Tenth Annual Sentinel Initiative Public Workshop.
Several stakeholders support an FDA plan to reduce the amount of risk information in DTC broadcast ads, while one opposes it.