Elena Catherine Klonoski

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

DOJ Announces $2.92 Billion in False Claims Act Recoveries in Fiscal Year 2024

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality

Medicare Drug Price Negotiation Program Final Guidance

The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?