HHS · no agency ID · record R0852

AI for Regulatory Review (AIRR) Pilot

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: Health and Medical
Operational functions: No function tag matched Derived by keyword rules; see methodology

Problem the AI is intended to solve

The AI-assisted regulatory review paradigm addresses the inefficiency and administrative burden of manually searching through vast amounts of disconnected sponsor-submitted and FDA-generated documents by integrating three components: AI-powered prompt engineering for streamlined workflows, real-time regulatory data retrieval systems, and automated document formatting capabilities that maintain human oversight while significantly enhancing review efficiency and consistency.

Expected benefits

Enables faster and more efficient regulatory reviews by reducing time spent on document searching and information gathering, allowing FDA reviewers to focus on scientific analysis and decision-making. Maintains high review quality while improving consistency across review teams and reducing administrative burden on expert reviewers.

System outputs

Preliminary administrative or review summary (available in Word format) for reviewers' verification and refinement

Technology

AI classification: Generative AISource: Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
System name(s): Not reported
Custom-developed code: No
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): In-house (CDER staff) and contractor teams
Vendors (standardized): None on the standard list

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: No FDA data were used to train, fine-tune or evaluate
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