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Janet Woodcock is the FDA’s Principal Deputy Commissioner. In this role she works closely with the Commissioner of Food and Drugs to develop and implement key public health initiatives and helps oversee the agency’s day-to-day functions.
She served as the Acting Commissioner of Food and Drugs from Jan. 20, 2021 until Feb. 17, 2022.
Dr. Woodcock began her FDA career in 1986 at the Center for Biologics Evaluation and Research (CBER). At CBER, she served as Director of the Division of Biological Investigational New Drugs and as Acting Deputy Director. She later became Director of CBER’s Office of Therapeutics Research and Review, which oversaw the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis during her tenure.
In 1994, Dr. Woodcock was named Director of the FDA’s Center for Drug Evaluation and Research (CDER), leading the Center’s work that is the world’s gold standard for drug approval and safety. There she conceived and implemented many of the FDA’s drug initiatives, including introducing the concept of risk management as a new approach to drug safety; modernizing drug manufacturing and regulation through the Pharmaceutical Quality for the 21st Century Initiative; advancing medical discoveries from the laboratory to consumers more efficiently under the Critical Path Initiative; launching the Safety First and Safe Use initiatives designed to improve drug safety management within and outside the FDA, respectively; developing the Sentinel Network for drug safety and spearheading CDER efforts on patient-focused drug development.
In 2004, Dr. Woodcock became the FDA’s Deputy Commissioner and Chief Medical Officer. Later she took on other executive leadership positions in the Commissioner’s Office, including Deputy Commissioner for Operations and Chief Operating Officer.
In 2007, Dr. Woodcock returned as Director of CDER until she was asked to be the therapeutics lead for “Operation Warp Speed” in early 2020. This entailed supporting the development, evaluation, and availability of treatments such as monoclonal antibodies and antiviral drugs for patients with COVID-19.
Dr. Woodcock holds a Bachelor of Science in chemistry from Bucknell University (Lewisburg, PA), and a Doctor of Medicine from the Feinberg School of Medicine at Northwestern University Medical School (Chicago). She also completed further training and a fellowship in rheumatology, as well as held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She is board certified in internal medicine.
Dr. Woodcock has been bestowed numerous honors over her distinguished public health career, most notably: the Nathan Davis award from the American Medical Association in 1999; the Roger W. Jones Award for executive leadership from American University in 2000; the VIDA award from the Society for Hispanic Health and the first Leadership Award in Personalized Medicine from the Coalition for Personalized Medicine in 2005; the Garry Neil prize for Innovation in Drug Development in 2009; a Lifetime Achievement Award in 2015 from the Institute for Safe Medication Practices; the Florence Kelley Consumer Leadership Award in 2017 from the National Consumers League; and the 2019 Biotechnology Heritage Award from the Biotechnology Innovation Organization and Science History Institute.