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Presently a partner in the Washington, D.C. law firm of Hyman, Phelps & McNamara, P.C., Mr. Sasinowski also serves as the FDA counsel to the Avicena Group. In this role, he advises the company on regulatory strategies, as well as presentations to the FDA.
Prior to joining Hyman, Phelps & McNamara, P.C. in 1987, Mr. Sasinowski held the position of regulatory counsel in the Office of Compliance, Office for Drugs and Biologics at the FDA. During his time with the FDA, he helped complete the DESI drug review and was involved in implementation of the ANDA portion of the 1984 Hatch-Waxman Act. He also played a major role in the early development of the Orphan Drug Act regulations and guidelines, and twice received the FDA's Award of Merit.
Mr. Sasinowski currently serves on the board of directors for the National Organization for Rare Disorders (NORD), the patient organization representing those afflicted with orphan diseases, and the Catholic Medical Missions Board, an organization that has donated over $100 million in medical supplies and services to underserved people around the world. In May 2000, NORD presented the NORD Humanitarian Award to Mr. Sasinowski for his continuing commitment to orphan drug development and his passionate advocacy for the continuing success of this unique legislation.
Mr. Sasinowski has previously served as an officer in the American Public Health Association and taught health law at American University. He received a B.S. degree in biological sciences and genetics from Cornell University, two M.S. degrees in nutritional sciences and public health from the University of California, Berkeley, and a Juris Doctorate from the Georgetown University Law Center.
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