CBER director Peter Marks and Brown University medical school professor Eli Adashi say it appears that decentralized clinical trials are a paradigm wh...
A National Mucopolysaccharidoses Society commentary urges FDA to use accelerated approval for promising treatments for rare diseases.
Doctors for America calls on FDA to finalize a guidance on collecting race and ethnicity data in clinical trials and clinical studies.
FDA warns Banten, Indonesia-based P.T. Sankei Medical Industries about Quality System and Medical Device Reporting violations in the manufacturing of ...
FDA approves an Aquestive Therapeutics ANDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of freq...
FDA clears a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac joint fusion construct.
Federal Register notice: FDA makes available a draft guidance entitled Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public...
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...
