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Regulatory Oversight › Machine Learning › Pharmaceutical Industry

Hogan Lovells

FDA launches “Elsa” AI tool to aid drug approvals

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The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more

Morgan Lewis - As Prescribed

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

Morgan Lewis - As Prescribed on

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

Gardner Law

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

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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

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

Loeb & Loeb LLP on

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Goodwin

What’s Next for AI? Six Areas to Watch in 2024

Goodwin on

Generative AI (GenAI) surged to the forefront of corporate agendas and public policy debates last year, promising to boost productivity and innovation. What’s in store for AI in 2024?...more

Hogan Lovells

Five highlights from FDA’s new AI device regulation Action Plan

Hogan Lovells on

On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more

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