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U.S. Department of Health and Human Services

About FDA

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Meet Karen Midthun, M.D., Director, Center for Biologics Evaluation and Research

Karen Midthun, M.D.

Dr. Midthun is the Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.

Dr. Midthun and center staff are committed to facilitating the development of biological products and providing oversight throughout the product life cycle.  Examples of these activities include

  • reviewing and providing advice during product development
  • conducting research that supports product development
  • evaluating applications and making approval decisions based on safety and effectiveness data
  • monitoring the safety of biological products

“Biological products touch people’s lives on a daily basis with over 200 million vaccinations, 29 million transfusions of blood and blood components, and 1.6 million musculoskeletal tissue transplants each year,” says Dr. Midthun. “Many of the products we regulate are vital for the public health, such as pandemic influenza vaccines and life-saving blood products. I’m proud to lead a team whose efforts help the timely development of safe and effective products to meet these needs.”

Dr. Midthun previously served as the deputy director of CBER and the director of the Office of Vaccines Research and Review within CBER.

Before joining FDA in 1993, Dr. Midthun was on the faculty of the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, where she was involved in the clinical development of investigational vaccines and was an attending physician at the Johns Hopkins Hospital.

Dr. Midthun received her bachelor’s degree from the Massachusetts Institute of Technology and her medical degree from the George Washington University School of Medicine. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases. She is a fellow of the Infectious Diseases Society of America and a member of the American College of Physicians and the American Society for Virology.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448