The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
1/24/2025
/ Artificial Intelligence ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
1/16/2025
/ Artificial Intelligence ,
Cybersecurity ,
Data Privacy ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Machine Learning ,
Medical Devices ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency