Annual Report CMC
Description
FDA receives numerous annual reports from drug manufacturers containing important manufacturing and quality information, but key details can be difficult to locate quickly within lengthy documents.
Detailed example
Support information extraction from unstructured documents
AI / analytics pattern
Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Objective of this use case was to assist in extracting Chemistry, Manufacturing, and Controls (CMC) changes reported within unstructured annual report industry submission documents to help build a complete repository for downstream analysis and more efficient regulatory review.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Applicant submissions