Tag: generic drug approval
Hatch-Waxman Act: How U.S. Law Made Generic Drugs Affordable
The Hatch-Waxman Act created the modern generic drug system in the U.S., balancing innovation and affordability. It saved over $1.7 trillion in healthcare costs and now governs 90% of prescriptions.
Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications
Learn how the FDA decides which generic drug applications get fast-tracked with priority review versus standard review. Understand the criteria, timelines, and new U.S. manufacturing incentives that shape generic drug access.
How the FDA Ensures Generic Drug Safety Through Manufacturing Oversight
The FDA ensures generic drugs are as safe and effective as brand-name versions through strict bioequivalence testing, mandatory manufacturing standards, and ongoing inspections-both domestic and international. Every step is monitored to protect public health.
