Smart Solution for Docket Management (SSDM)
Description
The AI is intended to solve the extremely labor-intensive and time consuming process of manually collating, de-duplicating, and categorizing public comments on FDA dockets.
Detailed example
The AI-enabled tool provides two main outputs: 1) a line listing excel file that organizes comments into groups based on similarity/deduplication thresholds and tags them with AI-identified and SME-approved keywords and topics; and 2) a comment summary word report that provides structured analysis of themes, key performance indicators, and submitter group breakdowns to assist in regulatory decision-making.
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
1. Significant time and resource savings: The platform aims to save the Agency a substantial number of staff hours by assisting in reducing redundant and time-consuming tasks that can take weeks to complete manually. 2. Enhanced processing capacity: The platform will enable FDA to effectively handle large-scale comment volumes. 3. Improved accuracy and quality: The AI-powered deduplication, topic modeling, and keyword flagging can potentially enhance the overall quality of comment processing while reducing human error in manual sorting.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Public comments on various FDA dockets