Tag: generic drug approval
20Mar
FDA Authorization of Generics: Legal Basis and Approval Process
The FDA approves generic drugs through a science-based process rooted in the 1984 Hatch-Waxman Act. Generics must match brand drugs in active ingredients, strength, and bioequivalence, ensuring safety and affordability. Over 90% of U.S. prescriptions are for generics, saving billions annually.