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 Institute 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 the Duke-Margolis Institute for Health Policy
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
Policy Analyst
Events About U.S. Food and Drug Administration
More EventsEvent 3/19-3/20/2024
Enhancing Adoption of Innovative Clinical Trial Approaches
WASHINGTON, DC
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, is…
Read MoreEvent 1/23-1/24/2024
Advancing Drug Development for the Prevention of Spontaneous Preterm Birth
Duke-Margolis under a cooperative agreement with the U.S. Food and Drug Administration (FDA), is…
Read MoreEvent 12/14/2023
Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement
This public meeting will expand upon the FDA’s current efforts by highlighting and building upon…
Read MoreEvent 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 MorePublications About U.S. Food and Drug Administration
More PublicationsIssue Brief
Considerations for FDA’s New Advanced Pharmaceutical Manufacturing Programs
Stephen Colvill, Cameron Joyce, Thomas Roades, Gerrit Hamre
Stephen Colvill, Cameron Joyce, Thomas Roades, Gerrit Hamre
2024
Read MoreOp-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 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...
Read MoreNews 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