how long does orphan drug approval take
The Orphan Drug Act 1983 (P.L. 97-414) as it amended the Federal Food, Drug and Cosmetic Act (FFDCA), and subsequent amendments, have shaped the US Orphan Drug Program. Under the FFDCA, the developer of an orphan drug product is guaranteed seven years of market exclusivity after FDA approval of the product.Drugs, biologics, medical devices and medical foods (mainly parenteral nutrition and nutraceuticals) can be given âorphanâ status.nder the FFDCA, the developer of an orphan drug product is guaranteed seven years of market exclusivity after FDA approval of the product. Drugs, biologics, medical devices and medical foods (mainly parenteral nutrition and nutraceuticals) can be given âorphanâ status.