Tag: FDA ANDA requirements
ANDA Process: Legal Requirements for Generic Drug Approval in the U.S.
- By : Tamsin Riverton
- Date : Jan 26 2026
The ANDA process is the legal pathway for generic drug approval in the U.S., governed by the Hatch-Waxman Act. It requires bioequivalence, identical active ingredients, and strict manufacturing standards to ensure safety and affordability.
