Tag: generic drug approval

3 Jan

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

Bioequivalence waivers let generic drug makers skip costly human trials when their products meet strict scientific criteria. Learn how the FDA approves these waivers using dissolution tests instead of blood samples.

How FDA Ensures Generic Drug Quality During Manufacturing

The FDA ensures generic drug quality through strict cGMP standards, unannounced inspections, and real-time monitoring of manufacturing processes. Learn how the agency guarantees that low-cost generics are just as safe and effective as brand-name drugs.