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...
Federal Register notice: FDA withdraws the approval of 23 NDAs from multiple applicants because they are no longer marketed.
FDA launches a collaboration to develop a Home as a Healthcare Hub prototype to help patients, healthcare providers, and industry.
FDA approves an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Gurin (BCG) for treating patients with BCG-unre...
