Catherine Pilgrim-Grayson is the Acting Director of the Division of Rare Diseases and Medical Genetics at the US FDA, providing scientific, clinical and technical direction on all medical and scientific decisions and judgment in connection with the review and evaluation of drugs in that arena. She advances OND's policies and research agenda for rare diseases, liaising with other FDA offices and other regulatory agencies, industry, professional organizations, academia, and the public. In addition to overseeing several recent approvals for drugs to treat rare inborn errors of metabolism with unmet need, an important recent Division accomplishment is the establishment of the Genetic Metabolic Diseases Advisory Committee, which provides the FDA independent, knowledgeable advice and recommendations on key issues around medical products for genetic metabolic diseases. In prior roles at FDA she was a Clinical Reviewer, acting Clinical Team Leader, acting Deputy Director and the Deputy Director for Safety. Dr. Pilgrim-Grayson is a board-certified obstetrician/gynecologist. She graduated from Swarthmore College with Honors, the University of Pennsylvania Perelman School of Medicine and the Johns Hopkins Bloomberg School of Public Health with Honors. She completed her Gynecology and Obstetrics residency at the Johns Hopkins Medical Institutions, and had a varied clinical career before coming to FDA, in academic medicine at Johns Hopkins, leading the Johns Hopkins Fibroid Center and teaching, conducting research and international public health outreach. Dr. Pilgrim-Grayson has also previously held a faculty position at Thomas Jefferson University, leading the Obstetrics and Gynecology clinic, and has served as the Chief of the Department of Obstetrics and Gynecology at the University of Maryland St. Joseph Medical Center.