Tag: GDUFA

Why Generics Get Stuck: Understanding FDA Tentative Approval Delays

Explore why generic drugs get stuck with tentative FDA approval, from patent litigation and citizen petitions to manufacturing gaps and market economics.

Generic Drug User Fee Amendments: How GDUFA Laws Speed Up FDA Reviews

GDUFA laws let the FDA collect fees from generic drug makers to speed up reviews, cut backlogs, and ensure affordable medications reach patients faster. Here's how it works and why it matters.