Federal Register notice: FDA releases a revised draft guidance entitled Assessing the Irritation and Sensitization Potential of Transdermal and Topica...
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 ...
The Justice Department seeks emergency relief from the U.S. Supreme Court after the Fifth Circuit Court of Appeals ruled that the abortion drug mifepr...
Federal Register notice: FDA makes available a draft guidance entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content.
