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Markham C. Luke, MD, PhD


Deputy Office Director for Clinical and Supervisory Medical Officer
Office of Device Evaluation, CDRH
Food and Drug Administration, HHS
(301) 796-5556

Markham has served as a Deputy Office Director in the Office of Device Evaluation (ODE), Center for Devices and Radiological Health, FDA since 2008.  In this capacity he works with the management and staff in the review Divisions in fulfilling the missions of the Office.  He supervises and works with the CDRH Advisory Panel Coordinator on Medical Device Advisory Committee meetings, and serves as ODE's interface to the Office of Compliance (OC), Office of Surveillance and Biometrics (OSB), and the CDRH ExecSec.  He is the Office supervisory liaison for the Medical Countermeasure, Emergency Preparedness, and Internal Communication programs.  ODE conducts premarket review of cutting edge therapeutic and diagnostic device technologies.  This component of the FDA evaluates the safety and effectiveness of new medical devices prior to their introduction into the marketplace. Markham has research interests in clinical study design, clinical endpoints assessment, and scale development (including patient-reported outcomes) for medical, surgical, and aesthetic products.  Markham is a strong advocate for medical device development for rare diseases and special populations.  He has interfaced with CDRH Staff College on developing reviewer training initiatives, and has been a preceptor and mentor for the FDA Commissioner�s Fellows Program since 2009.

Markham was born and raised in New York City where he attended Stuyvesant High School, and majored in Biochemistry at New York University.  He attended medical school at Johns Hopkins University for his MD degree, and studied under Professor Donald S. Coffey for his PhD in Pharmacology and Molecular Sciences.  Markham was an internal medicine intern at the Johns Hopkins Bayview Medical Center, Baltimore, Maryland and a dermatology resident at Washington University/Barnes Hospital, St. Louis, Missouri.  He served as PHS Fellow and Clinical Associate for Dermatology at the National Cancer Institute, NIH, beginning in 1997, followed by service as a Medical Officer reviewer at FDA, Center for Drug Evaluation and Research (CDER).  In 2001, he was selected as Lead Medical Officer for Dermatology drug products.  While at CDER, he was involved in various review and regulatory initiatives for dermatology drugs, in addition to serving as consultant dermatologist for other parts of FDA.  He also serves as an attending dermatologist at Bethesda National Naval Medical Center (now the Walter Reed Medical Center - WRMC), where he cares for dermatology patients (adult and pediatric) and teaches residents and medical students.  Markham continues to participate in weekly dermatology instructional and patient care activities at WRMC and NIH.





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