Explore the rigorous FDA standards for generic drug approval, including bioequivalence testing, manufacturing quality, and safety requirements that ensure generics are as effective as brand-name medications.
Explore how batch-to-batch variability impacts bioequivalence standards. Learn about the 80-125% rule, new BBE methods, and why multi-batch testing is becoming critical for generic drug approval.
The FDA authorizes generic drugs through the Hatch-Waxman Act and ANDA pathway, ensuring they match brand-name drugs in safety, strength, and effectiveness - while costing up to 85% less. Over 90% of U.S. prescriptions are for generics.