Renamed: Application References Previously: Application-DMF Reference
Description
FDA receives extensive drug application submissions that contain valuable references to related applications, but these relationships aren't always captured in existing regulatory databases.
Detailed example
Support information extraction from unstructured documents
AI / analytics pattern
Natural Language Processing: AI that processes, interprets, and shares information in human language.
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
Extracts references to Drug Master Files (DMFs) from marketing application submissions including Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and Biologics License Applications (BLA). These submission documents may be structured (356H form) or unstructured (electronic Common Technical Document modules 1-4). This pipeline parses content from these documents, extracts DMF references (e.g., ANDA123456 references DMF123456), and exposes the data in a structured format for analysis.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
applicant submissions