FDA publishes a guidance recognizing the latest revision of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood ...
Federal Register notice: FDA publishes a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices und...
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Federal Register notice: FDA makes available a draft guidance entitled Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public...
