FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials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
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FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices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
FDA Roundup: January 3, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-3-2025
Early Alert: Solution Set Issue from Baxter Healthcare Corporation
Early Alert: Fluid Delivery Set Issue from Medline
Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis
FDA Roundup: December 27, 2024
FDA Roundup: December 27, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-27-2024
FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-require-standardized-testing-methods-detecting-and-identifying-asbestos-talc