FDA approves a Gilead Sciences supplemental NDA for the use of Veklury (remdesivir) in Covid-19 patients with severe renal impairment, including those...
Federal Register notice: FDA seeks industry organizations interested in participating in the selection of nonvoting industry representatives to serve ...
FDA publishes a draft guidance with information on how it determines good cause for noncompliance with prescription drug section 505(o)(3) postmarketi...
Federal Register notice: FDA withdraws its 1/25 debarment of former Aegerion Pharmaceuticals sales representative Mark Moffett because an appeals cour...
Federal Register notice: FDA announces a 9/20 Pediatric Advisory Committee meeting to discuss artificial womb technology devices.
Oncology Center of Excellence associate director Harpreet Singh describes a new pilot program to outline performance criteria for lab-developed biomar...
FDA issues a second Warning Letter to Zyto Technologies in Lindon, UT, about its illegal marketing of the Zyto galvanic skin response hand cradle and ...
FDA publishes an online page describing hernias and their repair, with attention to using surgical mesh in the repair.
