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...
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.
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...
