Senators Mike Lee (R-UT), Ben Ray Lujn (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) introduce a bill to ease biosimilar interchangeability.
Federal Register notice: FDA makes available a draft guidance entitled Manufacturing Changes and Comparability for Human Cellular and Gene Therapy (CG...
Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompli...
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FDA publishes a draft guidance with information on how it determines good cause for noncompliance with prescription drug section 505(o)(3) postmarketi...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.
