Semantic Search of FDA Guidance Documents Using Generative AI.

Journal: Therapeutic innovation & regulatory science
Published Date: Jun 14, 2025

Abstract

INTRODUCTION: Generative artificial intelligence (AI) has the potential to transform and accelerate how information is accessed during the regulation of human drug and biologic products.

Authors

  • Scott Proestel
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Linda J B Jeng
    Division of Biomedical Informatics, Research, and Biomarker Development, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA. linda.jeng@fda.hhs.gov.
  • Christopher Smith
    Division of Biomedical Informatics, Research, and Biomarker Development, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA.
  • Matthew Deady
    International Business Machines (IBM), Washington D.C, USA.
  • Omar Amer
    International Business Machines (IBM), Washington D.C, USA.
  • Mohamed Ahmed
    BenevolentAI, 40 Churchway, London, NW1 1LW, UK.
  • Sarah Rodgers
    Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UK.

Keywords

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