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In Switch Label Studies, FDA Carefully Reads Data On Low-Literacy Consumers

 
• By Eileen Francis

Switch sponsors should include low-literacy subjects in label comprehension studies to address the “real risk” of taking an Rx product OTC, says a CDER Division of Nonprescription Drug Products social scientist. Self-selection studies similarly should include at-risk consumer populations.

Label comprehension studies for an Rx-to-OTC switch should clearly demonstrate levels of risk for low-literacy consumers, says James Stansbury, a social science analyst in FDA’s Division of Nonprescription Drug Products.

“What's the real risk when you think about this? It's the people with lower comprehension of the label who are...

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More from North America

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