The Inner Circle

 View Only
Back to discussions
Expand all | Collapse all

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

  • 1.  FDA Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

    Posted Jan 26, 2025 04:00:00 AM
      |   view attached

    Hi All,

    FDA recently released for comment: Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

    This guidance provides recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. Specifically, this guidance provides a risk-based credibility assessment framework that may be used for establishing and evaluating the credibility of an AI model for a particular context of use (COU).

    To submit comments online: https://www.regulations.gov/docket/FDA-2024-D-4689/document



    ------------------------------
    Michael Roza CPA, CISA, CIA, CC, CCSKv5, CCZTv1, MBA, EMBA, CSA
    ------------------------------