Mark
Raza
Leadership Role
Chief Counsel - Office of the Chief Counsel
Mark Raza has served as Chief Counsel since January 2021. Currently, he leads over 150 attorneys in FDA’s Office of the Chief Counsel (OCC). Previously he was the Principal Deputy Chief Counsel for over 10 years. Mr. Raza joined OCC in 1990 and has broad experience in the office’s practice areas. For example, he served as an agency ratifier for device and animal drug use fee reauthorization; managed the OCC device, human subject protections, and combination products teams; led the OCC emergency preparedness and response team during the COVID-19 pandemic; and functioned as the lead agency drafter for the Emergency Use Authorization provision in Project Bioshield in 2004. Mr. Raza has particular expertise in the law governing biological products, devices, emergency preparedness and response, and information disclosure. Early in his career he successfully represented FDA in both civil and criminal litigation involving all FDA product areas, including cases arising from the agency’s generic drugs task force. He also participated in FDA’s efforts in the 1990s to regulate tobacco. He served as an Acting Deputy Center Director for FDA’s Center for Devices and Radiological Health and was detailed to the former Office of Therapeutics Research and Review in the Center for Biologics Evaluation and Research. He is a graduate of Harvard Law School and Boston College.