FDA commissioner Robert Califf taps FDA principal deputy commissioner Janet Woodcock to counsel and support seven offices and Centers, but drugs and b...
Former FDA Digital Health Center of Excellence director Bakul Patel joins Google and Alphabet as a senior director for global health strategy and regu...
FDA says a Woodside Acquisitions recall of some 51,000 unapproved Covid-19 antigen tests is Class 1.
FDA clears a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System for use in pedicle screw preparation and placement.
FDA denies a portion of a 2019 petition asking for a Boxed Warning on breast cancer risk for combined hormonal contraceptives.
CDER Office of Surveillance and Epidemiology executives discuss the potential use of artificial intelligence in pharmacovigilance activities.
FDA clears an Oryx Dental 510(k) for its imaging product, Oryx Imaging that allows health professionals to acquire, view, annotate, and organize denta...
FDA clears a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System for use in pedicle screw preparation and placement.