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

The third component of the Drug Competition Action Plan is aimed at reducing 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. Such practices upset the careful balance that Congress sought between product innovation and access and can make the development and approval process unpredictable, and potentially more costly, for generic manufacturers.

To view the guidances listed below, go to Guidances for Drugs and filter by category Drug Competition Action Plan

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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

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