HHS · no agency ID · record R0854

CoreDF

Department of Health and Human Services · HHS/FDA/CDER

Overview

Development stage: PilotSource: b) Pilot – The use case has been deployed in a limited test or pilot capacity.
High-impact designation: Not high-impactSource: c) Not high-impact
Impact justification: Not reported
Start date: 2025-05 (month precision)Source: May-25
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Science
Operational functions: Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

Current nonclinical review processes require manual extraction and analysis of sponsor findings from lengthy PDF study reports, creating inefficiencies in data quality assessment and regulatory timeline.

Expected benefits

Expedites nonclinical review by extracting and organizing key safety findings from study reports, allowing FDA reviewers to focus on scientific evaluation and safety assessment rather than manual data extraction.

System outputs

Sponsor findings from non-clinical study reports

Technology

AI classification: Other
System name(s): CoreDF
Custom-developed code: Yes
Public source code: Not reported

Sourcing

How it was built: Contract and in-houseSource: c) Developed with both contracting and in-house resources
Vendor (as reported): IBM
Vendors (standardized): IBM

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII: No
Privacy Impact Assessment: Not reported
Authorization to Operate: Yes
Demographic features: k) None of the above
Training and evaluation data: non-clinical study reports (PDFs)
Federal Data Catalog: Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported