Federal Register notice: FDA extends the comment period on its 6/26-released Information Technology (IT) Strategy and Customer Experience Strategy....
Federal Register notice: FDA announces that OMB has approved an information collection entitled Survey on Quantitative Claims in Direct-to-Consumer Pr...
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.
