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Bioequivalence Waivers: When the FDA Allows Generic Drugs to Skip Human Trials

Bioequivalence Waivers: When the FDA Allows Generic Drugs to Skip Human Trials
Allison Wood Feb 13 2026

Bioequivalence waivers let the FDA approve generic drugs without human trials when lab tests prove they dissolve the same as the brand. This saves time, money, and gets affordable medicines to patients faster.

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