BrainStorm Cell Therapeutics says it has reached alignment with FDA on chemistry, manufacturing, and controls aspects of the companys upcoming Phase 3...
CDRH says it is partnering with the Bill and Melinda Gates Foundation and the National Institute for Standards and Technology on a project to develop ...
Federal Register notice: FDA submits to OMB a proposed information collection entitled Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP...
Federal Register notice: FDA requests comments on its Information Technology Strategy and Customer Experience Strategy.
FDA clears a Tempus AI 510(k) for its Tempus ECG-AF device that uses artificial intelligence to help identify patients at increased risk of atrial fib...
FDA clears a Fujifilm Healthcare Americas 510(k) for its new compact, 128-slice computed tomography (CT) system, the FCT iStream.
Public Citizen recommends three steps FDA should take to improve the public perception and understanding of the work of agency advisory committees.
FDA publishes a table with information on 14 drug submissions in FY 2023 that contained real-world evidence.
