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Tag: ANDA

Hatch-Waxman Act: How It Shaped Generic Drug Access in the U.S.
By Vincent Kingsworth 15 Dec 2025

Hatch-Waxman Act: How It Shaped Generic Drug Access in the U.S.

The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation and affordability. It slashed drug costs by 90% but also opened the door to patent abuse. Here’s how it works-and why it needs fixing.

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