Principal Investigator & Project Manager US Food and Drug Administration Somerville, Massachusetts
AskFDAGuidance is an advanced AI-powered chatbot developed through collaboration between data scientists at the FDA. This innovative platform facilitates efficient interaction with FDA guidance documents, providing accurate, traceable information and analytical insights. The platform leverages state-of-the-art Large Language Models (LLMs), natural language processing (NLP), and machine learning (ML) to ensure intelligent extraction and personalized content delivery specifically from FDA guidance documents. Its intuitive interface enables seamless document interaction, delivering traceable information alongside customized insights. Key features of AskFDAGuidance include: • Guidance Document Integration: Users can upload, preload, or reference FDA guidance documents, facilitating an innovative way to interact with regulatory guidance. • Intuitive Information Retrieval: The platform allows users to intuitively retrieve accurate, traceable information and analytical insights from guidance documents. • Advanced Analytics: AskFDAGuidance utilizes LLM, NLP, and ML for intelligent insight extraction and analytical generation, presented through interactive dashboards. • Customized Insights: The system delivers traceable and accurate information with customized insights, offering interactive dashboards for topic modeling, text summarization, and theme identification of guidance documents, which can be personalized to diverse user needs.
Learning Objectives:
Identify and explain three specific applications of AI and LLMs in streamlining document review, enhancing compliance monitoring, and improving regulatory decision-making in regulatory processes.
Critically assess advantages of AI-powered tools in regulatory operations while recognizing challenges in transparency, data privacy, and bias management when implementing AI in regulated environments.
Describe how AI and LLMs increase efficiency, accuracy, and consistency in regulatory operations, providing examples of leveraging these technologies to improve current regulatory practices.