Renamed: Module 3 Facilities Extraction Previously: Module 3 Faculties
Description
FDA receives drug application submissions (ANDA, NDA, BLA) that contain important manufacturing facility information in Module 3 documents, but this data requires manual review to identify and organize all facility details.
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 identifying and extracting all drug manufacturing facilities reported within unstructured module 3 submissions from marketing applications to build a comprehensive inventory of drug facilities for better regulatory oversight.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
applicant submissions