Tag: FDA approval
FD&C Act & Hatch-Waxman: The Legal Backbone of Generic Drugs
Explore how the FD&C Act and Hatch-Waxman Amendments created the legal framework for generic drugs, balancing patent protection with market competition to lower healthcare costs.
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Hatch-Waxman Act: How It Created the Modern U.S. Generic Drug System
The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation incentives with affordable access. It saved trillions but faces growing abuse.
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