The Challenges and Strategies for Today's Rx-to-OTC Switch Programs

Posted 13 December 2017 By Julie Aker, MT(ASCP)

This article presents the background, approaches and regulatory considerations for prescription to Over-the-Counter (Rx-to-OTC) switch programs. The US Food and Drug Administration (FDA) has conservative expectations for the studies supporting a switch in terms of methodologies and sample sizes. Because of this, other countries will sometimes give consideration of consumer studies conducted in foreign countries on a case-by-case basis, in place of studies conducted in the local country.

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Categories: Prescription drugs, Over the counter drugs, Features, US, FDA

Tags: OTC, OTC Switch

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