orphan drug definition FDA
Orphan drug. A term for a drug that treats a rare disease, defined by the Food and Drug Administration (FDA) as one that affects fewer than 200,000 Americans.The FDA has an Office of Orphan Products Development (OOPD), which offers grants to researchers to develop these products. term that generally refers to drugs needed to treat rare diseases but can encompass any pharmaceutic product available to physicians and patients in countries other than the United States that has not been adopted by a domestic pharmaceutic manufacturer or distributor.