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Hatch/Waxman Reinterpretation Underpins Change In 30-Month Stay Policy

This article was originally published in The Tan Sheet

Executive Summary

FDA's proposal to allow only one 30-month stay of approval for ANDAs hinges on a reinterpretation of Hatch/Waxman language declaring that patent holders must be notified if a generic application is amended to "include" a Paragraph IV certification
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