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Markham C. Luke, MD, PhD


Markham C. Luke, MD, PhD
Director, Division of Therapeutic Performance and Supervisory Medical Officer
Office of Research and Standards,
Office of Generic Drugs, CDER
Food and Drug Administration, HHS
(301) 796-5556

Since 2016, Markham serves as the Director of the Division of Therapeutic Performance in the Office of Research and Standards at FDA's Office of Generic Drugs.  The Division of Therapeutic Performance 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 research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products.  Markham is a strong advocate for medical product development for rare diseases and special populations.  He has interfaced with training staff on developing reviewer development initiatives in both CDRH and CDER, and has been a preceptor and mentor for the FDA Commissioner's Fellows Program since 2009.  In addition, Markham serves in the role of consultant dermatologist to various parts of FDA.

From 2008 to 2016, Markham served as the Chief Medical Officer and Deputy Office Director in the Office of Device Evaluation (ODE), Center for Devices and Radiological Health, where he was responsible for clinical oversight of the medical device evaluation process, evaluating and overhauling the Advisory Committee process and centralizing Panel staff.  He was also the Center liaison for Emergency Preparedness and the senior champion for various issues, including appropriate regulation of UV indoor tanning devices.

Markham was born and raised in New York City, attendee Stuyvesant High School, and majored in Biochemistry at New York University.  He obtained his MD degree at Johns Hopkins University, and completed PhD studies under Professor Donald S. Coffey in Pharmacology and Molecular Sciences.  Markham interned at the Johns Hopkins Bayview Medical Center and was 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, CDER's Office of New Drugs.  In 2001, he was selected as Lead Medical Officer for dermatology at FDA.

Markham serves as an attending dermatologist at Bethesda National Naval Medical Center (now the Walter Reed Medical Center - WRMC), instructor at the Uniformed Services University of the Health Sciences, and as a medical consultant for the National Institutes of Health.




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