Search Results for OTC Switch

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Marketing Exclusivity for Over-the-Counter Switched Products By Deborah Livornese - Published 19 December 2017

This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation.

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

Tags: OTC Switch, Marketing Exclusivity

Overview of the US Rx-to-OTC Switch Process By Wanda Azu Owoh - Published 19 December 2017

This article provides an overview of the US prescription (Rx) to Over-the-Counter (OTC) switch process, including full switch and partial switch, speaks to the importance of self-care for consumers, and discusses potential areas of opportunity for sponsors and/or industry.

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

Tags: OTC, OTC Switch

The Challenges and Strategies for Today's Rx-to-OTC Switch Programs By Julie Aker, MT(ASCP) - Published 13 December 2017

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.

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

Tags: OTC, OTC Switch