Tag: ANDA pathway
Federal Food, Drug, and Cosmetic Act: How It Built the Legal Foundation for Generic Drugs
The Federal Food, Drug, and Cosmetic Act laid the groundwork for generic drugs through the 1984 Hatch-Waxman Amendments, creating the ANDA pathway that lets safe, affordable generics enter the market. Today, 90% of U.S. prescriptions are filled with generics, saving consumers trillions.