Tag: bioequivalence waivers

Bioequivalence Waivers: When the FDA Allows Generic Drugs Without Human Trials

Bioequivalence Waivers: When the FDA Allows Generic Drugs Without Human Trials

The FDA allows generic drugmakers to skip human trials for certain medications using bioequivalence waivers. Here's how science-based in vitro testing replaces costly clinical studies - and saves patients money.