I am very pleased to announce the appointment of Melinda “Mel” Plaisier as the Associate Commissioner for Regulatory Affairs (ACRA), effective immediately. As many of you know, Melinda has been steadfastly serving in this position in an acting role since October 1, 2012. During that time, Melinda has led the Office of Regulatory Affairs (ORA), utilizing her deep operational knowledge, her proven leadership skills, and her professional and collaborative demeanor.
Melinda brings a wealth of experience to this position. She joined FDA in 1995, after serving as a Congressional staffer for more than a decade. Melinda spent more than 13 years in the Office of the Commissioner where, among other roles, she served as the Associate Commissioner for Legislation, providing executive leadership in directing and managing the Agency’s congressional relations and legislative activities, and the Associate Commissioner for International Programs, where she focused on negotiating international agreements and working with developing nations. Immediately prior to serving as the Acting ACRA, Melinda served as the Regional Food and Drug Director for ORA’s Central Region for several years.
Melinda will report directly to the Deputy Commissioner for Global Regulatory Operations and Policy and will lead the 4300 extraordinary men and women of ORA who are dedicated to furthering FDA’s public health mission in many important ways, including by inspecting regulated products and manufacturers, by conducting sample analysis on regulated products, and by reviewing imported products offered for entry into the United States.
Going forward, Melinda will play a critical role in helping FDA adapt to the continuing program-based specialization within FDA’s regulated industries and in implementing FDA’s expanded authority in recent groundbreaking legislation in many important areas. I am confident that Melinda will help position FDA as a public health regulatory agency fully prepared to deal with the many challenges of an increasingly complex global regulatory environment.
Please join me in congratulating Melinda as she assumes this official role.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs