FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.
The educational group Healthy Women petitions FDA to change fenofibrate labeling to state there is no proven cardiovascular benefit to using fenofibra...
FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemotherapy (carboplatin ...
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.
Three Alston Bird attorneys urge companies regulated by FDA to engage with the agency on issues involving artificial intelligence and machine learning...
