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Latest / Health and life sciences

PolicyHealthUSConfirmed

FDA issues first draft guidance on AI used in drug and biologic submissions

See how this story connects

Source: FDA

The FDA issued draft guidance with a risk-based framework for sponsors to establish the credibility of an AI model for a defined context of use when the model supports a regulatory decision on a drug or biological product’s safety, effectiveness or quality. The FDA called it its first guidance on AI in drug and biologic development.

Why it matters

Drug developers using AI to produce evidence for FDA submissions now have a framework for showing that the model is credible for its specific use.

When
6 Jan 2025
ID
WTA-N-2025-0173
Who
FDA

Summary by wheresthe.ai, from FDA. Checked against the source on 9 Oct 2026.

Read the original at FDA

Source copy: download the page as saved on 18 Oct 2026 (PDF). Also held by the Internet Archive.

Next stop on this Storyline: What happened nextFDA and EMA issue ten joint principles for AI in drug development

Data to measure this

Compare the years before 2025 with the years since in these series.

  • ETO Country AI Activity MetricsEmerging Technology Observatory, CSET (Georgetown)AI research articles and citations, AI patents and AI equity investment by country, year and field.monthly · download · CSV
  • WIPO: patent trends in generative AIWorld Intellectual Property OrganizationPublished generative-AI patent families by country, applicant, data type and model type.Years: 2014-2025 · one-off · report only · PDF · Covers before and after
  • OECD.AI: AI research publicationsOECD.AI (data from OpenAlex)AI publications and citations by country and institution, per capita and by quality tier.live · query tool
  • WIPO IP Statistics Data CenterWorld Intellectual Property OrganizationPatent, trademark and design indicators worldwide, with patents by class and 35 technology fields.annual · query tool

All data for United States

Cite this story

WTA-N-2025-0173: “FDA issues first draft guidance on AI used in drug and biologic submissions.” wheresthe.ai, 6 Jan 2025. https://wheresthe.ai/d/us-fda-ai-drug-development-draft-guidance-2025-01/ (source: FDA).

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