# Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19)

> **NIH FDA U19** · DUKE UNIVERSITY · 2021 · $873,663

## Abstract

PROJECT SUMMARY
 The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration’s (FDA)
is seeking proposals for collaborative research and convening activities to advance and promote regulatory
science and more efficient development of safe and effective drugs for patients in need. Building on almost ten
years of collaborative experience working with the FDA on such topics, the Duke-Robert J. Margolis, MD, Center
for Health Policy (Duke-Margolis) proposes to continue collaborating with CDER to tackle a range of policy,
scientific, and operational challenges as prioritized by FDA, the pharmaceutical industry, and Congress in 2018’s
Prescription Drug User Fee Act VI (PDUFA VI) and 2017’s 21st Century Cures Act (Cures). Through this new
cooperative agreement, and in keeping with goals in PDUFA VI and Cures to expedite development through
trusted science, Duke-Margolis proposes to expand on our existing collaboration with FDA by partnering with
CDER, C-Path, and experts within the Duke ecosystem to advance the following aims:
 Specific Aim 1: Implement a multidisciplinary and collaborative research and convening capacity to
support FDA and its stakeholders in addressing complex drug development and regulatory review challenges as
outlined in PDUFA VI and Cures. Our approach will incorporate a wide array of stakeholder perspectives,
facilitate the identification of practical and actionable solutions, and support the public health mission of FDA.
 Specific Aim 2: Synthesize and distill the core research, stakeholder input, and workshop or meeting
discussions pursued in Aim 1 to establish concrete, actionable next steps and recommendations for all
stakeholder groups, not just FDA, to pursue.
 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.

## Key facts

- **NIH application ID:** 10230979
- **Project number:** 5U19FD006602-04
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Marianne Hamilton Lopez
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $873,663
- **Award type:** 5
- **Project period:** 2018-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10230979

## Citation

> US National Institutes of Health, RePORTER application 10230979, Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) (5U19FD006602-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10230979. Licensed CC0.

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