
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

Adam Aten, MPH, MSc
Research Associate

Nicholas Harrison, MPH, MA
Senior Policy Analyst

Adam Kroetsch, MPP
Research Director, Biomedical Innovation and Regulatory Policy
Senior Team Member
Nirosha Mahendraratnam Lederer, PhD, MSPH
Managing Associate, Real World Evidence
Senior Team Member
2020 Intern Mentor

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

Thomas Roades, MPP
Policy Analyst

Morgan Romine, MPA
Chief of Staff
Senior Team Member

Sarah Sheehan, MPA
Managing Associate
Senior Team Member

Kelly Wahl, MPH
Research Associate

Marta Wosińska, PhD
Deputy Director, Policy, Duke-Margolis Center for Health Policy
Margolis Core Faculty
Consulting Professor, Duke-Margolis Center for Health Policy
Events About U.S. Food and Drug Administration
More EventsEvent 9/21/2021
Pharmacodynamic Biomarkers for Biosimilar Approval
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public…
Read MoreEvent 1/27/2021
Basic Research, Clinical Trial Infrastructure, and Community Engagement to Support Drug Development for ALS
Meeting Objective: Most cases of ALS, a progressive neurodegenerative disease, have no known cause…
Read MoreEvent 12/9/2019
Leveraging Clinical Pharmacology to Optimize Drug Development for Nonalcoholic Steatohepatitis (NASH) and Cholestatic Liver Diseases
SILVER SPRING, MD
There is significant unmet medical need in the prevention and treatment of nonalcoholic…
Read MoreEvent 10/16/2019
Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling
WASHINGTON, DC
Unanticipated, unrecognized, or mismanaged drug interactions are an important cause of morbidity…
Read MorePublications About U.S. Food and Drug Administration
More PublicationsProject 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 MoreWhite Paper
Trust, But Verify: Informational Challenges Surrounding AI-Enabled Clinical Decision Software
Christina Silcox, Isha Sharma, & Arti Rai.
Christina Silcox, Isha Sharma, & Arti Rai.
2020
Read MorePolicy Brief
Leveraging Clinical Pharmacology to Optimize Drug Development for Nonalcoholic Steatohepatitis (NASH) and Cholestatic Liver Diseases
Nicholas R. Harrison & Sarah Sheehan
Nicholas R. Harrison & Sarah Sheehan
2020
Read MoreJournal Article
Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs
Nicholas R. Harrison, Philip T. Sager, Mitchell W. Krucoff, Michael A. Weber, & William B. White
Nicholas R. Harrison, Philip T. Sager, Mitchell W. Krucoff, Michael A. Weber, & William B. White
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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