
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
Margolis Core Faculty

Nicholas R. Harrison, MPH, MA
Policy Research Associate

Trevan Locke, PhD
Assistant Research Director

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

Kristin Podsiad, MPH
Senior Policy Analyst

David Ridley, PhD
Professor of the Practice of Business and Economics
Margolis Executive Core Faculty

Thomas Roades, MPP
Senior Policy Analyst

Morgan Romine, MPA
Chief of Staff
Senior Team Member

Christina Silcox, PhD
Research Director, Digital Health
Adjunct Assistant Professor
Senior Team Member
Margolis Core Faculty

Erin Soule, PhD
Assistant Research Director

Mia Williams, MPH, CHES
Policy Analyst
Events About U.S. Food and Drug Administration
More EventsEvent 11/8/2023
15th Annual Sentinel Initiative Public Workshop
On November 8, 2023, the Duke-Margolis Center for Health Policy will host the 15th Annual Sentinel…
Read MoreEvent 9/18-9/19/2023
Optimizing the Use of Postapproval Pregnancy Safety Studies
WASHINGTON, DC
The public workshop will dedicate a portion of the meeting to allow for any public oral comments on…
Read MoreEvent 9/14/2023
The Future of Prescription Drug Promotion and Digital Marketing
The digital marketing landscape is a dynamic and rapidly evolving ecosystem, and marketers have a…
Read MoreEvent 6/8/2023
Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches
Innovative manufacturing technologies have the potential to improve the manufacture of…
Read MorePublications About U.S. Food and Drug Administration
More PublicationsOp-Ed
Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests
Scott Gottlieb, MD and Mark B. McClellan, MD, PhD
Scott Gottlieb, MD and Mark B. McClellan, MD, PhD
2022
Read MoreOp-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 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 More