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.
FDA sends AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuations in adults with ...
Federal Register notice: FDA makes available a final guidance entitled Laboratory Developed Tests (LDTs): Small Entity Compliance Guide.
FDA accepts for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with sertraline for treati...
