U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, MD, has appointed Robert Califf, MD, as the FDA Deputy Commissioner for Medical Products and Tobacco. Dr. Califf is a leader in cardiology, clinical research, and medical economics, who is currently serving as Vice Chancellor of Clinical and Translational Research at Duke University in Durham, North Carolina.
Dr. Califf will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.
Dr. Califf will play a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities, and he will manage clinical, scientific and regulatory initiatives in several key areas for the agency, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system.
“I am delighted to announce this important addition to the FDA’s senior leadership team,” said Dr. Hamburg. “Dr. Califf’s deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve upon, the significant advances we’ve made in medical product development and regulation over the past few years.”
Landmark Clinical Studies
In addition to his current position at Duke University, Dr. Califf has served in other prominent roles during his tenure at Duke, including Director of the Duke Translational Medicine Institute (DTMI) and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center. Before serving as Director of DTMI, he was the Founding Director of the Duke Clinical Research Institute.
During his career, Dr. Califf has led many landmark clinical studies and is a widely recognized expert in cardiovascular medicine, health outcomes research, health-care quality, and clinical research. He is a leader in the field of translational research, which is key to ensuring that advances in science translate into medical care.
Dr. Califf will join the FDA in late February 2015. ■