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Tag: generic drug approval

Hatch-Waxman Act Explained: How the 1984 Law Shapes Generic Drug Approval and FDA Policy
Kimberly Ashworth

Hatch-Waxman Act Explained: How the 1984 Law Shapes Generic Drug Approval and FDA Policy

Explore how the Hatch-Waxman Act revolutionized US generic drug policy by balancing patent protections with competitive market entry, shaping FDA approval processes and lowering healthcare costs.

18 May 2026

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