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Crestor Indication Grows User Pool, But Self-Selection Hinders Statin Switch

This article was originally published in The Tan Sheet

Executive Summary

Switching statins OTC will require comprehensive consumer education to enable self-selection and flexibility from FDA on the types of information it considers product labeling

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The division between product selection and purchase decisions is not as distinct as FDA suggests in the recent draft guidance on designing self-selection studies to support Rx-to-OTC switches, PEGUS Research's McCammon says

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The division between product selection and purchase decisions is not as distinct as FDA suggests in the recent draft guidance on designing self-selection studies to support Rx-to-OTC switches, PEGUS Research's McCammon says

Self-Selection Studies Need Room To Evaluate Purchase Decisions – Expert

FDA should allow researchers more flexibility to evaluate consumers’ purchase decisions in self-selection studies for OTC drugs, according to contract research organization PEGUS Research.

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