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Reopening Hatch-Waxman Is Decision For Congress, Not FDA, CDER’s Woodcock Says

Executive Summary

Responding to a lawmaker’s question on whether the incentives in Hatch-Waxman strike the appropriate balance, Center for Drug Evaluation and Research Director Janet Woodcock says the issue “is beyond my purview.”

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2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization

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