Tag: Hatch-Waxman Act

FDA Authorization of Generics: Legal Basis and Approval Process Explained

Learn how the FDA approves generic drugs under the Hatch-Waxman Act, the science behind bioequivalence, and why generics are safe, affordable, and critical to U.S. healthcare.

Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible

The Hatch-Waxman Act of 1984 created the legal framework that made generic drugs possible in the U.S., balancing innovation incentives with affordable access. Today, 90% of prescriptions are filled with generics thanks to this landmark law.

Tentative Approval and Litigation: Navigating the Path to Generic Drug Market Entry

Tentative approval from the FDA lets generic drug makers prepare for market entry while patents are still active. But missing deadlines or mismanaging litigation can cost millions. Here’s how to navigate the system and avoid costly delays.