
U.S. Food and Drug Administration
Duke-Margolis brings together external experts, the university’s leading research, education, and engagement capabilities, and the broader public to inform policymaking and the advancement of regulatory science at the U.S. Food and Drug Administration.
Projects Relating to U.S. Food and Drug Administration
Duke-Margolis Faculty & Research Team

Nancy Allen LaPointe
Faculty Fellow, Duke-Margolis Center for Health Policy
Adjunct Associate Professor in the Department of Medicine Faculty

Adam Aten, MPH, MSc
Research Associate

Ethan Chupp
Policy Analyst

Nicholas R. Harrison, MPH, MA
Research Associate

Trevan Locke, PhD
Research Associate

Herbert Kim Lyerly, MD
George Barth Geller Distinguished Professor of Surgery
Margolis Core Faculty

Mark McClellan, MD, PhD
Director of Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty

David Ridley, PhD
Dr. and Mrs. Frank A. Riddick Professor of the Practice of Business Administration
Margolis Executive Core Faculty

Thomas Roades, MPP
Policy Analyst

Morgan Romine, MPA
Chief of Staff
Senior Team Member

Christina Silcox, PhD
Digital Health Policy Fellow
Adjunct Assistant Professor
Senior Team Member
Margolis Core Faculty

Erin Soule, PhD
Assistant Research Director
Events About U.S. Food and Drug Administration
More EventsEvent 5/10/2022
Lessons Learned from Trial Replication Analyses: Findings from the DUPLICATE Demonstration Project
A public workshop to review findings from the RCT-DUPLICATE Demonstration Project. The discussion…
Read MoreEvent 4/12/2022
Duke-Margolis 2022 Inaugural Health Policy Conference
WASHINGTON, DC
The Duke-Margolis Inaugural Health Policy Conference will engage national health policy experts,…
Read MoreEvent 3/22/2022
AI/Machine Learning: Regulation, Development, and Real-World Performance Evaluation
On March 22, 2022 from 12:30 – 4:00 pm (EDT) the Duke-Margolis Center of Health Policy, with…
Read MoreEvent 1/24-1/25/2022
Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC)
Niemann-Pick Type C (NPC) is a rare genetic disease that results in progressive neurological…
Read MorePublications About U.S. Food and Drug Administration
More PublicationsOp-Ed
America needs a confirmed leader at FDA — now
Mark McClellan, Scott Gottlieb, and Margaret Hamburg and Andy Slavitt
Mark McClellan, Scott Gottlieb, and Margaret Hamburg and Andy Slavitt
2022
Read MorePolicy Brief
Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling
Nicholas R. Harrison, Sarah M. Sheehan, Mongthuong T. Tran, Jeanne Herndon, Eric
Brodsky, and Joseph A. Grillo
Nicholas R. Harrison, Sarah M. Sheehan, Mongthuong T. Tran, Jeanne Herndon, Eric
Brodsky, and Joseph A. Grillo
2021
Read MoreLetter
FDA Commissioners Letter of Support for Rob Califf
Andrew von Eschenbach, MD, Scott Gottlieb, MD, Stephen Hahn, MD, Margaret Hamburg, MD, Jane Henney, MD, Mark McClellan, MD PhD
Andrew von Eschenbach, MD, Scott Gottlieb, MD, Stephen Hahn, MD, Margaret Hamburg, MD, Jane Henney, MD, Mark McClellan, MD PhD
2021
Read MoreProject Report
Characterizing the FDA’s Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle
Nicholas R. Harrison and Sarah Sheehan
Nicholas R. Harrison and Sarah Sheehan
2020
Read MoreNews About U.S. Food and Drug Administration
More NewsPress Release July 23, 2019
Press Release: A Path For FDA, Consumers Toward More Effective Drug Safety Labeling
WASHINGTON, D.C. -- Changes by the Food and Drug Administration (FDA) to drug safety labeling are an important way to provide patients and providers with the most up-to-date information about a product’s risk.
WASHINGTON, D.C. -- Changes by the Food and Drug Administration (FDA) to drug safety labeling are an...
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News Update January 7, 2019
Former Commissioners Call for FDA to Become Independent Federal Agency
In a commentary published in Health Affairs, seven former FDA Commissioners call for the FDA to evolve into an independent federal agency in order to better support its core missions, foster efficiency, and remove administrative roadblocks.
In a commentary published in Health Affairs, seven former FDA Commissioners call for the FDA to...
Read MoreNews Update November 29, 2018
The FDA Sentinel Initiative — An Evolving National Resource
Duke-Margolis Center Director Mark McCellan, MD, PhD, co-authored a New England Journal of Medicine Perspective on the evolution and impact of the FDA’s Sentinel Network in the November 29 issue.
Duke-Margolis Center Director Mark McCellan, MD, PhD, co-authored a New England Journal of Medicine...
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