Improving public health through better drug policies and practices
Official title: Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed
Funded at Duke University · NIH-11115187 · Data updated 2026-11-12
This study is working with the FDA to make sure that medicines are safe and effective for everyone, and it aims to find better ways to develop and monitor these products, which could lead to safer treatments for patients like you.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Duke University NIH-funded |
| Lab location | 1 site (Durham, United States) |
| Project start | September 20, 2024 |
| Project end | August 31, 2029 |
| Funding year | 2024 |
| Award (this year) | $700,000 |
| NIH project number | 1U01FD008451-01 |
| Project ID | NIH-11115187 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for benefiting from this research include patients who rely on medications and medical products regulated by the FDA.
✕Less likely to help
Patients who are not using FDA-regulated medical products may not receive direct benefits from this research.
What this research studies
This research focuses on enhancing regulatory science and policy development related to medical products by collaborating with the FDA. It aims to address critical public health issues such as drug development, approval processes, and postmarket surveillance. By engaging a diverse range of stakeholders, the project seeks to identify actionable solutions that improve the oversight of medical products. Patients may benefit from improved safety and efficacy of drugs as a result of these enhanced policies.
Why it matters
Potential benefit: If successful, this research could lead to safer and more effective medical products for patients.
How similar studies have gone: Previous collaborative efforts between the FDA and research institutions have shown success in improving regulatory practices and public health outcomes.
Where this research is happening
-
Duke University
Durham, United States Active
Researchers
- Principal investigator: Hamilton Lopez, Marianne — Duke University
- Study coordinator: Hamilton Lopez, Marianne
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.