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Tag: Hatch-Waxman Amendments

Federal Food, Drug, and Cosmetic Act: How It Built the Legal Foundation for Generic Drugs
21 Jan 2026
Daniel Walters

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

The FD&C Act laid the groundwork for drug safety in the U.S., but it was the Hatch-Waxman Amendments that created the legal pathway for generic drugs. Today, 90% of prescriptions are generic-saving billions thanks to this system.

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