Tag: FDA bioequivalence

FDA Bioequivalence Standards for NTI Drugs: What You Need to Know
Rob Visor
29 Jan 2026
FDA Bioequivalence Standards for NTI Drugs: What You Need to Know

The FDA enforces stricter bioequivalence rules for NTI drugs like warfarin, digoxin, and phenytoin, requiring tighter potency limits and variability controls to ensure patient safety. Learn how these standards differ from regular generics.

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