FDA clears a DiaSorin 510(k) for its Simplexa Congenital CMV Direct kit, a molecular diagnostic test that detects cytomegalovirus DNA in saliva swab a...
FDA publishes a guidance on using definitions for device and counterfeit device.
FDA seeks comments on a draft guidance entitled Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5...
The CDER Office of Pharmaceutical Quality publishes a MAPP on its use of regulatory flexibilities to help overcome CMC readiness challenges for drug p...
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for SK Biopharmaceuticals Xcopri (cenobamate)....
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dutch Ophthalmics Tissueblue (brilliant blue g ...
Federal Register notice: FDA determines the regulatory review period for Esperion Therapeutics Nexletol (bempedoic acid), indicated as an adjunct to d...
AdvaMed asks FDA to consider adding more information to a draft guidance on ethical considerations for clinical investigations of medical products inv...
