Regulatory Starting Material
Description
FDA needs comprehensive visibility into the upstream supply chain for drug manufacturing, particularly tracking regulatory starting materials and their suppliers across approved and pending drug applications to better understand potential supply chain vulnerabilities.
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
Assists in extracting Regulatory Starting Materials (RSMs) and their suppliers from unstructured module 3 industry submissions to help create an inventory that will illuminate the upstream supply chain and help FDA identify potential supply chain vulnerabilities.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
applicant submissions