Two FDA officials describe steps the agency is taking to harmonize its oversight of clinical trials with the HHS Common Rule on protecting those who v...
FDA says Bayer is making inadequate progress in a postmarket surveillance study of its Essure birth control device.
FDA grants Eli Lilly a fast track designation for tirzepatide and its use for treating adults with obesity, or overweight with weight-related comorbi...
Federal Register notice: FDA sets the medical device user fee rates and payment procedures for fiscal year 2023.
FDA clears an Aurora Spine 510(k) for its SiLO TFX MIS Sacroiliac Joint Fixation System.
Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2023.
Researchers say Congress should consider giving FDA more authority to deal with companies that dont complete their postmarket commitments on time, inc...
FDA publishes two final guidances to facilitate the timely start and finish of medical device post-approval studies and postmarket surveillance.
