Tag: FDA approval
Hatch-Waxman Act: How It Shaped Generic Drug Access in the U.S.
The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation incentives with affordable access. It cut drug costs by billions but also opened the door to patent abuse and legal delays.
What is an ANDA? The Complete Guide to Abbreviated New Drug Applications
An ANDA is the FDA pathway that allows generic drugs to enter the market without repeating costly clinical trials. It's the reason 90% of U.S. prescriptions are filled with affordable generics, saving billions annually.