Are you curious about how the FDA uses large language models (LLMs) and artificial intelligence (AI) in its regulatory work? Scientists in NCTR’s Division of Bioinformatics and Biostatistics proposed a general framework for adopting LLMs and demonstrated the framework through AskFDALabel, a system customized to assist with drug labeling review. The findings show how AskFDALabel provides a more efficient, accurate, and reliable solution for extracting relevant information from drug labeling documents.