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Consumer OTC Drugs

OTC "Actual Use Studies" Subject To Financial Disclosure Requirements

This article was originally published in The Tan Sheet

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Executive Summary

"Actual use studies" conducted in support of Rx-to-OTC switch or direct-to-OTC new drug applications and used to show effectiveness in the OTC setting are subject to FDA's financial disclosure requirements, according to a draft guidance clarifying the agency's February 1998 final rule.
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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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