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Robert M. Califf

Instructor in the Department of Medicine
Medicine, Cardiology
Box 3533 Med Ctr, Durham, NC 27710
100 Trent Drive, SUITE401, Davison Building, Durham, NC 27710

Overview


Robert Califf, MD MACC, is an Adjunct Professor of Medicine in the Division of Cardiology and remains a practicing cardiologist. Dr. Califf was the Commissioner of Food and Drugs in 2016-2017 and Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as Commissioner in February 2016. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.

Dr. Califf is a Member of the National Academy of Medicine (formerly known as the Institute of Medicine (IOM)) in 2016, one of the highest honors in the fields of health and medicine. Dr. Califf has served on numerous IOM committees, and he has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging.

He has led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke's Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center and co-PI of the Patient Centered Outcomes Research Institute Network.

Current Appointments & Affiliations


Instructor in the Department of Medicine · 2025 - Present Medicine, Cardiology, Medicine
Member in the Duke Clinical Research Institute · 2025 - Present Duke Clinical Research Institute, Institutes and Centers

In the News


Published February 15, 2022
U.S. Senate Confirms Robert Califf as FDA Commissioner
Published January 10, 2022
DCRI Celebrates 25 Years of Improving Health Around the World
Published October 12, 2020
How Fast Should We Post a Vaccine to Market?

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Recent Publications


Recent Updates to the Declaration of Helsinki: A View from the U.S. Food and Drug Administration.

Journal Article Ther Innov Regul Sci · September 2025 This commentary provides the perspective of the U.S. Food and Drug Administration (FDA) on the World Medical Association's (WMA) recent updates to the Declaration of Helsinki, a foundational document in biomedical research ethics. We highlight the value of ... Full text Link to item Cite
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