
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 Food and Drug Administration
Duke-Margolis Faculty & Research Team

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

Brian Canter, PhD
Policy Research Associate

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
Policy Research Associate

Patrick Rodriguez, MA
Policy Analyst
2024 Margolis Intern
Molly Shields
Policy Research Assistant

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

Mia Williams, MPH, CHES
Policy Analyst
Events About Food and Drug Administration
More EventsEvent 12/10/2024
Mortality and Antipsychotic Use in Dementia-Related Behavioral Disorders
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, is…
Read MoreEvent 10/29/2024
Opportunities to Improve Dose-Finding and Optimization for Rare Disease Drug Development
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. Food and…
Read MoreEvent 9/24/2024
The Second Annual Future of Prescription Drug Promotion and Digital Marketing Meeting
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, is…
Read MoreEvent 8/20/2024
Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/Inspection: CMC for Biologics & Biosimilars
During this hybrid public meeting, FDA, sponsor companies, and other experts will explore the root…
Read MorePublications About Food and Drug Administration
More PublicationsJournal Article
Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities
An N. Massaro, MD, Beth Boyer, MPH, Mira Gill, MS, Dure Kim, PharmD, Matthew Laughon, MD, MPH, Michele Walsh, MD, Monica E. Lemmon, MD, Betsy Pilon, BA, and Gerri Baer, MD, on behalf of the Duke-Margolis/FDA Measuring Clinical Benefit in Neonatal RCTs Workshop Participants*
An N. Massaro, MD, Beth Boyer, MPH, Mira Gill, MS, Dure Kim, PharmD, Matthew Laughon, MD, MPH, Michele Walsh, MD, Monica E. Lemmon, MD, Betsy Pilon, BA, and Gerri Baer, MD, on behalf of the Duke-Margolis/FDA Measuring Clinical Benefit in Neonatal RCTs Workshop Participants*
2024
Read MoreIssue 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 MoreNews About 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 More
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...
Read More