Real World Data/Evidence
Description
FDA receives numerous submissions containing real-world data and evidence, but identifying and cataloging these studies across various submission types is time-intensive and critical for regulatory reporting requirements under PDUFA (Prescription Drug User Fee Act).
Detailed example
Supports extracting text from unstructured documents and tagging for documents containing Real World Evidence and Real World Data
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
Assist in identifying industry unstructured submissions containing Real World Data/Evidence (RWD/E) by analyzing parsed content for likely indicators to support congressional reporting and regulatory decision-making.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
applicant submissions