# Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities

> **NIH FDA U01** · DUKE UNIVERSITY · 2020 · $450,000

## 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 advance regulatory science, policy, and
procedures to address a range of critical public health topics, including drug development, drug approval,
bioresearch monitoring, human subject protection, and post market surveillance. Building on over 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 priority public
health issues. Through this new cooperative agreement Duke-Margolis proposes to expand on our existing
collaboration with FDA by partnering with CDER 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 to explore and address a range of critical public health topics related to FDA’s oversight of
medical products, policy, and surveillance methods and systems. 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:** 9999522
- **Project number:** 5U01FD006807-02
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Marianne Hamilton Lopez
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $450,000
- **Award type:** 5
- **Project period:** 2019-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999522

## Citation

> US National Institutes of Health, RePORTER application 9999522, Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities (5U01FD006807-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9999522. Licensed CC0.

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