The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
1/15/2025
/ Artificial Intelligence ,
Comment Period ,
Compliance ,
Data Management ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management
AI is vaulting drug discovery forward leaps and bounds—and now regulators are beginning to catch up, with the United States Patent and Trademark Office recently issuing new guidelines on the patentability of AI-assisted...more