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United States Drug Approval Standards Legislation

Senate OTC Monograph Reform Bill Clears HELP For Floor Vote

This article was originally published in The Pink Sheet & The Rose Sheet

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Executive Summary

Senate HELP Committee approves an OTC monograph reform bill with two-year market exclusivity for some products. The bill also establishes a user fee program to pay for FDA's work and replaces public rulemakings currently required for any change with an administrative order process.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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