Tag: FDA generic drugs

Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence

Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence

25 Jan 2026 by Arturo Dell

Bioequivalence ensures generic drugs work the same as brand-name ones. The FDA requires strict testing of absorption rates using Cmax and AUC metrics, with a 80-125% confidence interval. This science-backed standard keeps generics safe, effective, and affordable.