In honor of Women’s History Month, Big Molecule Watch will highlight the work of women who have contributed to the advancement of biologics and biosimilars. One such individual is Janet Woodcock, current acting Commissioner of the U.S. Food and Drug Administration (FDA) and director for Drug Evaluation and Research, who has held a number of key leadership positions since she joined the FDA in 1986. For over a decade, Dr. Woodcock served as Director of the Center for Drug Evaluation and Research (CDER), which oversees generic drug approvals. Dr. Woodcock worked as part of Operation Warp Speed to oversee development of COVID-19 therapies, including monoclonal antibody treatments for COVID-19 patients. According to the FDA, “[a]s Acting Commissioner, Dr. Woodcock oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products.” She has been awarded several honors over the course of her career including the 2019 Biotechnology Heritage Award from BIO.