Simonne Brousseau

Faegre Drinker Biddle & Reath LLP

+ Follow Contact

Latest Posts › Machine Learning

Share:

FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models

On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more

1/20/2025 / Artificial Intelligence , Biopharmaceutical , Compliance , Data Management , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Pharmaceutical Industry , Risk Management

FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...

On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more

1/13/2025 / Artificial Intelligence , Data Management , Data Privacy , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Regulatory Requirements , Risk Management

AI After the Election: Potential Differences Between a Harris Administration and a Second Trump Administration for Artificial...

To help health and life science companies remain current on artificial intelligence-related legal and regulatory expectations, we have published many updates on the United States and European Union AI initiatives. Even when...more

9/3/2024 / Artificial Intelligence , Biden Administration , Executive Orders , Machine Learning , Trump Administration

3 Results

View per page

Page: of 1