Speakers

Janet Woodcock recently completed a long career at FDA. She served as Director of the Center for Drug Evaluation and Research for over twenty years in several stretches. Most recently she served as Principal Deputy Commissioner and prior to that as Acting FDA Commissioner. She held multiple other senior positions at FDA including at the Center for Biologics Evaluation and Research. She was the therapeutics lead for “Operation Warp Speed” during the COVID pandemic. Her most recent effort was spearheading a major reorganization of FDA’s foods program and the Office of Regulatory Affairs. Dr. Woodcock completed many major regulatory initiatives during her FDA tenure. She was instrumental in getting the biosimilars legislation enacted and worked to ensure adoption in the clinical community. Additionally, she worked with industry and Congress to bring about the first GDUFA. After passage of the legislation, she oversaw an extensive reorganization of the generic drug review program at CDER, that successfully met the aggressive targets of the legislation and led to eventual reauthorizing, with elimination of backlogs and approval of thousands of generic drugs.