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Algorithms Prescription Drugs Food and Drug Administration (FDA)

Gardner Law

FDA Goes All In on AI: What It Means for Your Submissions

Gardner Law on

The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more

King & Spalding

FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review

King & Spalding on

On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

ArentFox Schiff on

Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

Womble Bond Dickinson

Computer Science Meets Medicine in Drug Discovery

Womble Bond Dickinson on

AI has the potential to revolutionize healthcare worldwide. In drug discovery, AI has already shown success. Sumitomo Dainippon Pharma and the UK-based AI company Exscientia developed DSP-1181 to treat obsessive compulsive...more

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