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
Project
Rare Disease Innovation, Science, and Exploration Workshop Series
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. FDA, is co-convening the Rare Disease Innovation, Science, and Exploration (RISE) Workshop series with the Rare Disease Innovation Hub. With many rare diseases lacking approved therapies these patient populations face unique challenges to medical product development, including small patient populations,...
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. FDA, is...
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Project
Artificial Intelligence in Health Care Portfolio
Duke-Margolis AI researchers are devoted to harnessing the potential of safe, trustworthy, and responsible AI to transform health care
Duke-Margolis AI researchers are devoted to harnessing the potential of safe, trustworthy, and...
Read MoreDuke-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
Assistant Policy Research Director
Nicholas R. Harrison, MPH, MA
Policy Research Associate
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
Valerie J. Parker, MSc
Assistant Policy Research Director, Regulatory & Real-World Data and Evidence
Kristin Podsiad, MCRP, MPH
Policy Research Associate
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 Analyst, Assistant
Christina Silcox, PhD
Research Director, Digital Health
Adjunct Assistant Professor
Senior Team Member
Margolis Core Faculty
Mia Williams, MPH, CHES
Senior Policy Analyst
Alissa Wong, MSPH
Policy Analyst, Assistant
Events About Food and Drug Administration
More EventsEvent 4/29/2026
U.S. Food and Drug Administration Webinar on the RCT-DUPLICATE Initiative: Emulating Randomized Clinical Trials with Non-Randomized Real-World Data Studies
On Wednesday, April 29, 2026, the FDA is hosting a free public webinar to provide updates on RCT…
Read MoreEvent 4/23/2026
Increasing Access to Nonprescription Drugs
This hybrid public meeting, convened by the Duke-Margolis Institute for Health Policy under a…
Read MoreEvent 4/14/2026
Scaling Innovative Clinical Trial Approaches: Challenges, Progress, and Opportunities
WASHINGTON, DC
This hybrid workshop, co-convened by the Duke-Margolis Institute for Health Policy and the U.S…
Read MoreEvent 3/30/2026
RISE Together: Data Sharing Across the Rare Disease Ecosystem
WASHINGTON, DC
This public workshop, co-convened by the Duke-Margolis Institute for Health Policy and the FDA Rare…
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
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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
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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
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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 News
News Update April 2, 2025
Press 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...
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