Federal Register notice: FDA updates its listing of product-specific draft and revised draft guidances that provide recommendations on the design of b...
Federal Register notice: FDA announces a 9/28 virtual public meeting entitled Reauthorization of the Prescription Drug User Fee Act.
Cardinal Health recalls its Argyle UVC Insertion Tray because it does not include specific instructions for using the safety scalpel N11 contained in ...
FDA posts its Prescription Drug User Fee Act VII commitment letter that describes enhancements to the program that will take place beginning 10/1/2022...
FDA Review posts the Federal Register notice for the week ending 8/20/2021.
FDA Review posts product approval summaries for the week ending 8/20/2021.
Federal Register notice: FDA has determined that Janssen Pharmaceuticals Ortho-Cept (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 ...
FDA issues a safety alert reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical devices for ...