FDA publishes a final guidance with recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty balloon and specialty ...
GlaxoSmithKline asks the Supreme Court not to hear Tevas appeal of an adverse appeals court decision in a skinny label case for its generic form of GS...
Federal Register notice: FDA issues a final order to exempt certain categories of biological products from certain annual reporting requirements.
FDA accepts for review a AlgoDx de novo marketing request for Navoy Sepsis, a clinical decision support software for predicting sepsis in adult patien...
FDA says a Philips Web site report on the number of replacement and remediated BiPAP and CPAP devices shipped to consumers overstates the number that ...
Federal Register notice: FDA makes available a final guidance entitled A Risk- Based Approach to Monitoring of Clinical Investigations Questions and ...
Federal Register notice: CDRH announces its Radiation Sterilization Master File Pilot Program, a voluntary program for companies that terminally steri...
FDA publishes a draft guidance recommending the content and format for submitting OTC monograph order requests to the agency.
