Tag: FDA generic approval

Federal Food, Drug, and Cosmetic Act: How It Built the Legal Foundation for Generic Drugs

by Joseph Michael Thompson

Federal Food, Drug, and Cosmetic Act: How It Built the Legal Foundation for Generic Drugs

9 Jan, 2026

The FD&C Act laid the legal groundwork for generic drugs through the 1984 Hatch-Waxman Amendments, creating the ANDA pathway that lets generics prove equivalence without costly trials. Today, 90% of U.S. prescriptions are generic, saving consumers trillions.