Tag: ANDA process
Hatch-Waxman Act Explained: How It Controls Generic Drug Approval and Prices
By Lindsey Smith On 4 Aug, 2026 Comments (0)
The Hatch-Waxman Act balances brand-name patent protection with generic drug competition. Learn how the ANDA process, Orange Book, and 180-day exclusivity drive down costs and improve access.
View MoreHow Generic Drugs Are Made: The Full Manufacturing Process Explained
By Lindsey Smith On 22 Mar, 2026 Comments (13)
Generic drugs are just as effective as brand-name medications but cost 80-85% less. This article explains the full manufacturing process, from bioequivalence testing to FDA-approved production, and how quality is maintained every step of the way.
View More