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  1. Office of Global Regulatory Operations and Policy

Ginette Y. Michaud, MD, Director, Office of Biological Products Operations

Ginette Y. Michaud, MD, Director, Office of Biological Products Operations

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 Ginette Michaud 

Ginette Y. Michaud is the director of the Office of Biological Products Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). She previously served in the Center for Biologics Evaluation and Research as deputy director of the Office of Blood Research and Review. Prior to 2009, Dr. Michaud was a regulator at the Center for Devices and Radiological Health, first in the Office of In Vitro Diagnostics and subsequently in the Office of Device Evaluation.

Throughout her career at FDA, Dr. Michaud has been involved in international regulatory capacity building, global regulatory harmonization, and in developing national and international technical standards and reference materials.

Dr. Michaud is managing the transition to a product-based program that encompasses complex biological products and their related devices. Dr. Michaud is a hematologist and a hematopathologist with twenty years of regulatory experience.