Markham Luke, MD, PhD

Division Director, Division of Therapeutic Performance I, ORS, OGD, CDER

Markham C. Luke, MD, PhD 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 been at FDA since 1998 serving various roles, including as the Lead Medical Officer for dermatology drugs in the Office of New Drugs at CDER, Chief Medical Officer and Deputy Director for the Office of Device Evaluation in CDRH, and as Acting Director for Cosmetics in CFSAN. Markham has an MD degree and a PhD in Pharmacology from Johns Hopkins University, internal medicine training at Johns Hopkins Bayview Medical Center, and dermatology residency and fellowship at Washington University, St. Louis, MO and at NCI/NIH, Bethesda, MD. Markham is an Associate Professor in Dermatology at the Uniformed Services University of the Health Sciences, Bethesda, MD.  Markham has research interests in dermato-pharmacology, clinical pharmacology, product innovation and design – especially for combination drug-device products, 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.

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