Four Democrat senators and representatives say the U.S. Patent and Trademark Office should weigh a new Merck patent request for a subcutaneous formula...
Federal Register notice: FDA announces a 4/25 public meeting entitled Patient-Focused Drug Development for Long Covid.
FDA releases the form FDA-483 issued following an inspection at the Ahmedabad, India-based Amneal Pharmaceuticals Private Limited parenteral manufactu...
CBER director Peter Marks discusses four lessons learned from the rapid development of Covid-19 vaccines and the implications for the future.
Federal Register notice: FDA determines that Allergans Asacol HD (mesalamine) delayed-release tablet, 800 mg, was not withdrawn due to safety or effec...
Federal Register notice: FDA determined that Janssens Topamax (topiramate) sprinkle capsules, 50 mg, was not withdrawn due to safety or effectiveness ...
The Association for Accessible Medicines praises the FDA revision of a draft guidance on generic drug controlled correspondence to meet new GDUFA 3 ag...
FDA publishes three guidances on aspects of x-ray system regulation.
