# Cooperative Agreement to Support Regulatory Research Related to the 2022 Prescription Drug User Fee Act and Biosimilar User Fee Act (U19)

> **NIH FDA U19** · DUKE UNIVERSITY · 2024 · $1,006,000

## Abstract

PROJECT Summary
The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is
seeking proposals for collaborative research and convening activities to advance and promote regulatory science
in several key areas prioritized by the FDA, the pharmaceutical industry, and Congress in 2022’s Prescription
Drug User Fee Act VII (PDUFA VII) and Biosimilar User Fee Act (BsUFA III). Building on more than fourteen
years of collaborative working experience with the FDA on priority topics, the Duke-Robert J. Margolis, MD,
Center for Health Policy (Duke-Margolis) proposes to continue collaborating with the FDA to tackle the range of
policy, scientific, and operational challenges identified in PDUFA VII and BsUFA III.
Duke-Margolis will build on its past experience to work collaboratively with FDA to identify priority topics for
development and delivery of up to nine collaborative research and convening activities that include the annual
completion of up to four large public conferences, two private expert workshops, and three other convening
activities (e.g., think tanks, webinars) as needed and achievable under the annual budget. Depending on the
intended convening purpose or need, convenings may be virtual, hybrid, or in-person. Through this new
cooperative agreement, and in keeping with goals in PDUFA VII and BsUFA III to expedite development through
trusted science, Duke-Margolis proposes to expand on our existing infrastructure, extensive stakeholder
relationships, convening experience and expertise, and positive track record of collaboration with numerous FDA
Centers and Offices to achieve the following aims:
Specific Aim 1: Implement a multidisciplinary, multi-stakeholder, and collaborative research and convening
program to support FDA and its stakeholders in addressing complex drug development and regulatory review
challenges as outlined in PDUFA VII and BsUFA III.
Specific Aim 2: Synthesize and distill the core background research, stakeholder input, and workshop or meeting
discussions pursued in Aim 1 to promote and establish concrete, actionable next steps and recommendations
for all stakeholder groups.
Specific Aim 3: Disseminate the findings and recommendations developed under Aim 2 to the public in a
transparent and timely method, with an eye toward continually engaging stakeholders to further refine and
implement key concepts and recommendations where feasible and appropriate.
Duke-Margolis is uniquely suited to collaborate with the FDA to advance research in the key areas identified in
PDUFA VII and BsUFA III. We seek to build on our senior team’s fourteen years of experience working
collaboratively with the FDA through other such cooperative agreements to engage stakeholders on high-
priority questions of interest, develop recommendations and models for making progress, and advance
regulatory science and more efficient development of safe and effective drugs for patients in need.

## Key facts

- **NIH application ID:** 10840930
- **Project number:** 5U19FD006602-07
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Marianne Hamilton Lopez
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $1,006,000
- **Award type:** 5
- **Project period:** 2018-09-01 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10840930

## Citation

> US National Institutes of Health, RePORTER application 10840930, Cooperative Agreement to Support Regulatory Research Related to the 2022 Prescription Drug User Fee Act and Biosimilar User Fee Act (U19) (5U19FD006602-07). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10840930. Licensed CC0.

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