Tag: Hatch-Waxman Amendments
Federal Food, Drug, and Cosmetic Act: Legal Foundation for Generic Drugs
The Federal Food, Drug, and Cosmetic Act laid the legal groundwork for generic drugs in the U.S., with the 1984 Hatch-Waxman Amendments creating the ANDA pathway that allows safe, affordable generics to reach patients. Today, they fill 90% of prescriptions.
