Solgenix says FDA is requiring an additional study to resolve a refuse-to-file letter it received for its HyBryte (synthetic hypericin) NDA for lympho...
FDA clears a Moximed 510(k) for its MISHA Knee System, an implantable shock absorber for use in patients with medial knee osteoarthritis.
FDA posts a 13-page Form FDA-483 addressed to Lupin LTD. that cites significant GMP deficiencies from a 03/21-29 inspection.
Federal Register notice: FDA releases a revised draft guidance entitled Assessing the Irritation and Sensitization Potential of Transdermal and Topica...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...
