FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality

Lexology January 16, 2025
Morrison & Foerster LLP

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of AI on intellectual property, licensing, contracts, regulatory policy, enforcement, privacy, and venture markets in life sciences.

On January 6, 2025, FDA published a draft nonbinding guidance document setting out a framework for drug sponsors, manufacturers, and other interested parties (referred to as “sponsors”) to evaluate the credibility of AI models producing data or information intended to support:

• FDA regulatory determinations regarding a drug’s safety, effectiveness, or quality (i.e., approval of a New Drug Application), or
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