FDA Roundup: January 10, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-10-2025

FDA Roundup: January 7, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-7-2025

http://www.fda.gov/safety/medical-product-safety-information/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and

FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-including-tissue-biopsies-clinical-trials

FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
http://www.fda.gov/news-events/press-announcements/fda-proposes-framework-advance-credibility-ai-models-used-drug-and-biological-product-submissions

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
http://www.fda.gov/news-events/press-announcements/fda-issues-comprehensive-draft-guidance-developers-artificial-intelligence-enabled-medical-devices

FDA Roundup: January 3, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-3-2025

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-solution-set-issue-baxter-healthcare-corporation

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-fluid-delivery-set-issue-medline

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-extracorporeal-blood-circuit-issue-nuwellis