Federal Register notice: FDA seeks information to better understand the status of trading partners interoperable systems and processes for enhanced dr...
A new final rule outlines five standards that the agency says drug marketers must follow to ensure their direct-to-consumer advertisements major state...
Bayer stops its Phase 3 OCEANIC-AF study evaluating asundexian compared to apixaban (Bristol-Myers Squibbs Eliquis) in patients with atrial fibrillati...
FDA warns healthcare professionals not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia pumps while the ag...
Janssen Pharmaceutical files a supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for tre...
FDA issues Dr. Reddys Laboratories a 10-item Form FDA-483 after an inspection 10/27 at the firms Telangana, India manufacturing facility.
Federal Register notice: FDA makes available a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of...
Federal Register notice: FDA announces a 2/6/2024 advisory committee meeting on medical device supply chain resiliency and shortage issues.
