GxPlex

FDA AI guidance

Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products

final

Last verified: Last observed: no observation recorded Tier: 1 · Sector: pharma
Authority
US Food and Drug Administration
Jurisdiction
US
Status
final
Effective date
—
Last changed
—
Last verified
:
Watch cadence
weekly
Crawlable
yes · renders server-side · returns non-200 to an AI-agent user-agent
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) fda.gov
Topics
artificial intelligence · credibility assessment

Current status#

Recorded as final against the primary source on 2026-07-28. See the evidence record for the text that supported it.

Scope#

FDA draft guidance describing a risk-based credibility assessment framework for AI models used to support regulatory decision-making.

Key dates#

No dates have been verified against the primary source for this entry.

Sources#

Cite this instrument

Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products [instrument record]. Observed 27 July 2026. https://gxplex.com/instrument/fda-ai-guidance Primary source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents

BibTeX

@misc{gxplexinstrumentfdaaiguidance,
  author       = {{GxPlex}},
  title        = {{Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products}},
  year         = {2026},
  note         = {instrument record, observed 27 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/fda-ai-guidance}},
  urldate      = {2026-07-28},
  url          = {https://www.fda.gov/regulatory-information/search-fda-guidance-documents}
}

APA

GxPlex. (2026). Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products [instrument record]. Retrieved 27 July 2026, from https://gxplex.com/instrument/fda-ai-guidance

Observation history

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Sources

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