Tag: ANDA process
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.
FDA Generic Drug Approval: Step-by-Step Process for ANDA Submission
- By : Tamsin Riverton
- Date : Dec 31 2025
Learn the complete step-by-step FDA generic drug approval process through the ANDA pathway, including pharmaceutical equivalence, bioequivalence testing, CMC requirements, and how generics save billions in healthcare costs.
