FDA Drug Competition Action Plan | Closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended

FDA aims to reduce the so-called “gaming” that frustrates and delays generic drug approvals and extends brand monopolies beyond what Congress intended with the Hatch-Waxman Amendments of 1984.

Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news