FDA adds three new tools to the Catalog of Regulatory Science Tools to Help Assess New Medical Devices and updates listings for five existing tools.
FDA commissioner Robert Califf tells a Senate HELP hearing that FDA inspection, diagnostic devices, and supply chain transparency reforms are needed.
FDA and the Duke-Margolis Center for Health Policy announce a 6/7-8 public workshop on the agencys Rare Disease Endpoint Advancement Pilot Program.
Federal Register notice: FDA announces a 6/15 advisory committee to select strain(s) to be included in the Covid19 vaccines for the 20232024 season.
Federal Register notice: FDA creates a docket to receive public comments on the identification, assessment, and control of N-nitrosamine drug substanc...
FDA issues a complete response letter for Novo Nordisks concizumab, asking for additional dosing and manufacturing information.
FDA issues a warning on SD Biosensors Pilot Covid-19 At-Home Tests due to bacterial contamination concerns with its liquid solution.
More than 250 Democrat members of the House and Senate petition the 5th Circuit Court of Appeals to overturn a Texas federal court decision banning th...
