Dr. Markham C. Luke, MD, PhD, FAAD, is the Director of the Division of Therapeutic Performance in FDA’s Office of Generic Drugs. He oversees regulatory science research to establish therapeutic equivalence standards for complex generic drugs and translating that research into product specific guidance documents and meetings and correspondence with industry. A board-certified dermatologist with an MD and PhD in Pharmacology from Johns Hopkins, he has served at FDA since 1998 in various leadership and management roles, including the Office of New Drugs, the Center for Devices and Radiological Health, and FDA’s Cosmetics Office.