Former FDA principal deputy commissioner Joshua Sharfstein and other medical school professors say FDA should not exempt from premarket notification C...
FDA clears a BrainCool AB 510(k) for the IQool System, intended for use for temperature reduction in adult patients when clinically indicated.
Former FDA commissioner Robert Califf accepts split positions as vice chancellor for health data science for Duke Health and senior manager at Verily ...
AstraZeneca petitions FDA to require certain conditions for a Teva 505(b)(2) application referencing Faslodex IM injection as the listed drug.
FDA clears an Exactech 510(k) to market the ExactechGPS Shoulder Application that combines preoperative planning with computer-assisted shoulder arthr...
Former FDA deputy commissioner William Schultz makes the case for not relaxing the agencys efficacy standard to allow drug companies to provide truthf...
FDA approves a Vertex Pharmaceuticals expanded use of Kalydeco (ivacaftor) for treating cystic fibrosis.
Former FDA commissioner Robert Califf accepts split positions as vice chancellor for health data science for Duke Health and senior manager at Verily ...