Tag: FDA approval
Hatch-Waxman Act: How It Made Generic Drugs Possible in the U.S.
by TexTheme in Healthcare
4 Mar 2026
The Hatch-Waxman Act of 1984 created the modern U.S. generic drug system, balancing innovation incentives with affordable access. It cut approval costs, sped up generic entry, and saved trillions - but also opened doors to patent manipulation.
30-Month Stay: How Litigation Delays Generic Drug Approval
by TexTheme in Healthcare
8 Dec 2025
The 30-month stay under the Hatch-Waxman Act delays generic drug approval by freezing FDA action during patent lawsuits. While meant to protect innovation, it's often used to extend monopolies, costing patients billions annually.