Olympus recalls its high-flow insufflation units (model UHI-4) that are used in laparoscopic surgeries after receiving reports about patients sufferin...
Researchers from several U.S. academic medical centers suggest steps FDA and CMS could take to tighten CMS supplemental reimbursement for new medical ...
Federal Register notice: FDA releases a draft guidance entitled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facili...
Qiagen and Myriad Genetics announce a collaboration to develop cancer companion diagnostic tests.
CDERs Office of Prescription Drug Promotion launches a new Web page to display untitled letters issued for drug advertising and promotion violations.
Sens. Grassley and Warren urge FDA to quickly voice its support for including a device identifier on Medicare claims forms.
After reporting favorable study data in those aged 50-59 years, GSK says it will seek FDA approval for an expanded use of Arexvy (respiratory syncytia...
Federal Register notice: FDA sends to OMB an information collection revision entitled Standardized Reporting Forms for FDA Federally Funded Public Hea...
