Tag: bioequivalence
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.
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.
Bioequivalence of Combination Products: Special Testing Challenges Explained
Bioequivalence testing for combination products like fixed-dose pills, topical creams, and inhalers is far more complex than for single-drug generics. Learn why these products face higher failure rates, longer approval times, and why new testing methods are urgently needed.
