FDA warns Royal Philips about Quality System and Medical Device Reporting violations at its medical device manufacturing facility in Suzhou, China.
Federal Register notice: FDA makes available its annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarket...
Federal Register notice: An FDA advisory committee schedules a 5/23 meeting to review a Guardant Health PMA for its Shield blood test for colorectal c...
FDA says most applicants completed or released most of the premarketing requirements or commitments reported in the agencys FY 2022 annual report.
Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Social and Behavioral Research as Used by ...
Endos Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone particulates in the p...
Exactech recalls its Equinoxe Shoulder System devices packaged in defective bags from facilities unused inventory.
FDA warns against the use of over-the-counter anti-choking devices because they are not approved or cleared by the agency.
