RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    CDRH Compliance Director Silverman Leaving FDA

    The longtime director of the Center for Devices and Radiological Health's (CDRH) Office of Compliance, Steve Silverman, plans to leave the US Food and Drug Administration (FDA) next week to pursue other opportunities, press officials have confirmed to Regulatory Focus . Silverman has been a central figure in CDRH's " Case for Quality ," an effort to improve compliance among medical device manufacturers by focusing on common quality errors across the device industry. "We...
  • Former FDA Commissioner: Approve Drugs Based on Safety, Prove Efficacy Later

    Former US Food and Drug Administration (FDA) Commissioner Andrew Von Eschenbach has an op-ed in the 14 February edition of the Wall Street Journal in which he calls for some drugs to be approved based on only premarket indications of safety, with testing on efficacy and effectiveness to be left for postmarket studies. "[T]here is a growing recognition-at the agency, in the industry and among patients' groups-that it is at serious risk of falling behind its core res...