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Markham Luke

Markham C. Luke MD, PhD, FAAD

Director and Supervisory Physician (Dermatology), Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland; Associate Professor, Department of Dermatology, Uniformed Services University of the Health Sciences, Bethesda, Maryland

Markham C. Luke, MD, PhD, FAAD, serves as FDA Supervisory Physician (Dermatology) and Director of the Division of Therapeutic Performance (DTP) in the Office of Research and Standards, Office of Generic Drugs at FDA. DTP is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has an MD and a PhD in Pharmacology from Johns Hopkins University and completed his dermatology residency and fellowship at Washington University, St. Louis, MO and the  National Institutes of Health, Bethesda, MD. Markham is an Associate Professor at the Uniformed Services University of the Health Sciences, Bethesda, MD.  Markham has research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products and serves as consultant dermatologist to various parts of FDA. Markham has been at FDA since 1998 serving various roles, including as the Lead Medical Officer for dermatology drugs, Chief Medical Officer and Deputy Director for the Office of Device Evaluation in the Center for Devices and Radiologic Health, and as Acting Director for Cosmetics in the Center for Food Safety and Applied Nutrition. In each of these roles including his current one, Markham has been involved in programs and initiatives dealing with product innovation as related to public health for our nation.

Disclosures

Dr. Luke has no relevant disclosures.