Yale University researchers say FDA should consider three ways to enhance the timely and robust assessment of drug safety signals from FAERS.
FDA clears a Boston Cell Standards 510(k) for its IHControls panel (HER2/ER/PR) for evaluating breast cancers.
CDER and CBER partner with the Critical Path Institute to plan for a consortium to facilitate clinical development programs for alpha-1 antitrypsin de...
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.
