FDA renews Certaras legacy licenses for its GlobalSubmit drug and biologics review software for another year.
Federal Register notice: FDA determines that Hospiras atropine sulfate ansyr plastic syringe was not withdrawn due to safety or effectiveness reasons....
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Med-El Electromedizinische Gerates medical devi...
Federal Register notice: FDA seeks comments on an information collection extension for Human Tissue Intended for Transplantation 21 CFR Part 1270.
FDA publishes the first in a series of guidances with standards for medical device submissions in electronic format.
House Energy and Commerce chair Frank Pallone (D-NJ) says the current youth vaping epidemic could have been averted if FDA in 2017 had not delayed rev...
FDA grants breakthrough therapy designation to Achillion Pharmaceuticals danicopan for treating paroxysmal nocturnal hemoglobinuria.
FDA approves Abiomeds newest heart pump, the Impella 5.5 with SmartAssist, indicated for temporary ventricular support (14 days) and for treating ongo...