The Sedgwick Recall Index says medical device recalls soared in the second quarter of 2022, while drug recalls remained level with the first quarter.
Federal Register notice: FDA makes available a draft guidance entitled Hydrogen Peroxide- Based Contact Lens Care Products: Consumer Labeling Recommen...
FDA lifts a partial clinical hold on the Curis TakeAim Lymphoma study of emavusertib.
Federal Register notice: FDA makes available a final guidance entitled Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Device...
Federal Register notice: FDA announces a 10/6 Vaccines and Related Biological Products Advisory Committee meeting to discuss the vaccine strain select...
FDA approves a Bayer sNDA for its Mirena intrauterine system for extended use of up to eight years as a contraceptive.
FDA accepts for priority review an Astellas Pharma NDA for fezolinetant, a nonhormonal compound for treating moderate to severe vasomotor symptoms (ho...
FDA warns about the potential for needle stick injuries from recently recalled Haiou Needle Retractable Safety 1 mL syringe with 23G 1-inch needle and...
