Regulatory Innovation and Strategic Modernization Pathways Service

Overview

Healthcare Services, Wellness & Biotech

United StatesPosted about 1 month agoDeadline: April 30th, 2026

Fit Score

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SUMMARY

RFP for strategic modernization of regulatory pathways to strengthen public health oversight, with emphasis on innovation, real-world data, AI, and patient access to investigational therapies.

KEY REQUIREMENTS

Must be the Reagan-Udall Foundation for the Food and Drug Administration
Must have an active System for Award Management (SAM) registration
Must have an active eRA Commons account
Must have an active Grants.gov registration
Must be a U.S. organization
Must have a Data Management and Sharing Plan
Must comply with all applicable federal anti-discrimination laws
Must align with current Executive Orders and President's policy priorities

BUDGET

Verified

$1,300,000

CONTRACT DURATION

60 months

TIMELINE

Posted Date: March 31st, 2026

Open Date: March 31st, 2026

Application Due Date: April 30th, 2026

Expiration Date: May 1st, 2026

Issuing Agency

U.S. Food And Drug Administration

Organization overview and procurement intelligence available on paid plans.

See Issuer Research

DESCRIPTION

This opportunity seeks a vendor to provide regulatory innovation and strategic modernization pathways services through the PRISM cooperative agreement. The initiative aims to advance public health by reinforcing scientific, collaborative, and operational frameworks essential for modernizing regulatory oversight in a rapidly evolving public health environment.

Vendors will support efforts to enable the nation to adapt regulatory science approaches for ensuring timely access to safe, effective, and high-quality products, including products, diagnostics, foods, and digital health. The selected provider will focus on advancing the use of real-world data, real-world evidence, and artificial intelligence to enhance public health and regulatory science. Additionally, strengthening access pathways for patients to investigational therapies, such as through expanded access programs, is a core element of the project.

Source attribution

This Settle analysis is based on the issuing organization’s public RFP listing.