FDA principal deputy commissioner Janet Woodcock explains the components of the agencys new Enterprise Modernization Action Plan.
FDA updates its communications about Philips Respironics recalls of ventilators and BiPAP and CPAP machines.
Three medical device stakeholders express support for a proposed FDA change to the quality system regulation to incorporate an international standard ...
Public Citizens Sidney Wolfe and Weill Cornell Medical College professor Martin F. Shapiro urge medical journals to step up their transparency efforts...
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.