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AER experiment gets OMB approval

This article was originally published in The Tan Sheet

Executive Summary

A proposed experiment by FDA's Center for Drug Evaluation and Research designed to identify statements that most effectively convey OTC and Rx AER data to consumers has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995, FDA announces. The agency proposed the experiment, "Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension" following a proposed rule in 2004 requiring all OTCs approved under an NDA or ANDA to add a toll-free number and other statement to product labeling for AER purposes (1"The Tan Sheet" April 26, 2004, p. 14)...

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