FDA Generic Drug Approval: How the ANDA Process Works
- Garrett Sorenson
- 7 07 2026 Medication Guides
Explore how the FDA regulates generic drug approval through the ANDA process, ensuring bioequivalence and safety under the Hatch-Waxman Act.
Explore how the FDA regulates generic drug approval through the ANDA process, ensuring bioequivalence and safety under the Hatch-Waxman Act.
Generic drugs are just as safe and effective as brand-name drugs but cost 80-85% less. Learn how the FDA ensures they work the same, when to choose generics, and why most prescriptions are filled with them.