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Tag: generic drug approval

Hatch-Waxman Act: How U.S. Law Made Generic Drugs Fast, Affordable, and Legal
  • 21 Feb, 2026
  • Sean Luke
  • 11 Comments

Hatch-Waxman Act: How U.S. Law Made Generic Drugs Fast, Affordable, and Legal

The Hatch-Waxman Act of 1984 created the legal pathway for generic drugs in the U.S., balancing innovation and competition. It cut approval costs, spurred generic entry, and saved over $1.7 trillion in healthcare spending.

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