Packaging Materials and Suppliers
Description
FDA needs to efficiently identify which Drug Master Files (DMFs) contain specific packaging materials and understand how these materials connect to drug applications, but this information is currently difficult to locate across numerous 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 is to extract data from unstructured sources to assist in building an inventory of drug packaging materials and their suppliers to support staff in conducting drug supply chain analysis for better regulatory oversight.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Applicant submissions