Three stakeholders provide requested input to FDA on the risks and benefits of non-device software functions.
FDA warns Indias Brassica Pharma about CGMP violations in its production of finished drugs at a facility in Thane, India.
FDA warns Criticare Technologies about QS violations in its manufacturing of patient monitors at a medical device facility in Warwick, RI.
FDA posts answers to frequently asked questions about its new laboratory-developed test final rule.
Merck reports positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab in treating respiratory syncytial virus...
Experts from FDA and two other groups publish considerations for the use of overall survival as an endpoint in cancer clinical trials.
FDA accepts a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL, indicated for treating diabetic macular edema and diabetic ret...
FDA clears a Think Surgical 510(k) for its Tmini Miniature Robotic System with Tmini 1.1. software for total knee arthroplasty procedures.
