Silver Star Brands recalls six products for humans (including four Native Remedies and two Healthful Naturals and two PetAlive products after testing ...
The New Jersey Supreme Court dismisses 532 failure-to-warn cases alleging that Roche failed to provide adequate warnings about the risk of inflammator...
Two stakeholders praise an FDA pilot meeting program for complex innovative drug trial designs.
FDA clears an Allergan 510(k) for its CoolSculpting nonsurgical fat reduction device to treat the submandibular (below the jawline) area.
FDA approves Genentechs Hemlibra for a new prophylaxis indication for hemophilia A in patients without factor VIII inhibitors.
A citizen petition asks FDA to withdraw drug dissolution guidances and the dissolution database because dissolution testers have not been validated fo...
Unplug the Robot activist Jennifer Nelson asks FDA to consider banning and recalling all DaVinci Robot permanent cautery instruments.
Federal Register notice: FDA makes available a final guidance entitled Selection of the Appropriate Package Type Terms and Recommendations for Labelin...