AI for Regulatory Review (AIRR) Pilot
Description
The AI-assisted regulatory review paradigm addresses the inefficiency and administrative burden of manually searching through vast amounts of disconnected sponsor-submitted and FDA-generated documents by integrating three components: AI-powered prompt engineering for streamlined workflows, real-time regulatory data retrieval systems, and automated document formatting capabilities that maintain human oversight while significantly enhancing review efficiency and consistency.
Detailed example
Preliminary administrative or review summary (available in Word format) for reviewers' verification and refinement
AI / analytics pattern
Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
Automation level / stage
b) Pilot – The use case has been deployed in a limited test or pilot capacity.
Expected benefit
Enables faster and more efficient regulatory reviews by reducing time spent on document searching and information gathering, allowing FDA reviewers to focus on scientific analysis and decision-making. Maintains high review quality while improving consistency across review teams and reducing administrative burden on expert reviewers.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
No FDA data were used to train, fine-tune or evaluate