Tag: ANDA

Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
The first generic drug filer gets 180 days of exclusive market rights under U.S. law. But this rule, meant to speed up affordable drugs, is now being used to delay competition. Here’s how it works-and why it’s changing.
Generic Drug Approval Standards: Safety, Quality, and Strength Requirements
Generic Drug Approval Standards: Safety, Quality, and Strength Requirements
Learn how the FDA ensures generic drugs meet the same safety, quality, and strength standards as brand-name medications through bioequivalence testing, strict manufacturing rules, and rigorous inspections.