FDA posts a draft guidance entitled Inspection of Injectable Products for Visible Particulates.
CDRH Office of Product Evaluation and Quality director William H. Maisel tells an industry conference that the agency is planning to release very soon...
FDA says fact sheets for the Janssen Covid-19 vaccine have been updated with a Contraindication for the vaccine in individuals with a history of throm...
FDA issues a draft guidance on the redesignation of the definition of device in the Federal Food, Drug, and Cosmetic Act and the addition of a definit...
Federal Register notice: FDA classifies the nonimplanted nerve stimulator for functional abdominal pain relief into Class 2 (special controls).
Federal Register notice: FDA classifies the endoscopic transhepatic venous access needle into Class 2 (special controls).
Federal Register notice: FDA proposes to require PMAs for spinal spheres for use in intervertebral fusion procedures.
A health and science policy analyst for Citizens Against Government Waste says the Build Back Better act proposed by President Biden will hurt the gen...