On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more
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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
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
The U.S. Food and Drug Administration is all about hard science, and correlation of variables is not evidence of causation. To make a regulatory decision, FDA has long held that line, requiring evidence of actual occurrences...more
A week before the EU’s AI Act comes into force on August 1, the White House announced that U.S. agencies have completed all actions required by President Biden’s AI Executive Order to date. Meanwhile, the Republican Party...more
It’s been a busy summer for the National Institute of Standards and Technology (NIST) and the U.S. AI Safety Institute (itself housed within NIST). July 26, 2024, marked the 270th day since President Biden issued his...more
Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more
On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a...more