CDER and CBER announce seven participants in the START pilot program to speed development of treatments for rare diseases.
FDA releases the form FDA-483 with five observations from an inspection at the Torrent Pharmaceuticals facility in Indrad, Gujarat, India.
FDA grants a de novo marketing authorization to Cepheid for its Xpert HCV test and GeneXpert Xpress System for detecting hepatitis C virus.
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.
