Orphan Designation

Orphan Designation. Means orphan status provided to pharmaceuticals, biologics, medical devices and medical food intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders meeting certain criteria in the United States specified in the Orphan Drug Act and FDA's implementing regulations at 21 CFR Part 316, and including foreign equivalents thereof, including, criteria provided by the European Medicine's Agency's Committee for Orphan Medicinal Products (COMP), the Australian... Government's Department of Health, Therapeutic Goods Administration, and the Ministry of Health, Labour and Welfare of Japan. View More