Tag: generic drug approval

2 May, 2026

What is an ANDA: Abbreviated New Drug Application Explained for FDA Approval

by Trevor Ockley | May, 2 2026 | | 0 Comments

Discover what an ANDA is and how it enables generic drug approval. Learn about the Hatch-Waxman Act, bioequivalence testing, and why this process saves the healthcare system billions.

18 Dec, 2025

Generic Drug User Fees: How FDA Funding Speeds Up Access to Affordable Medicines

by Trevor Ockley | Dec, 18 2025 | | 14 Comments

Generic Drug User Fee Amendments (GDUFA) fund the FDA's review of generic medications, cutting approval times from years to months. Learn how user fees keep affordable drugs flowing to patients.