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OTC switch meeting

This article was originally published in The Rose Sheet

Executive Summary

FDA will consider adequacy of current structure for marketing OTC products and the agency's role in switch products at a public hearing June 28-29. The agency also seeks comments on criteria to consider in deciding on OTC availability of drugs; the classes of any Rx products that should be considered for OTC treatment; consumer understanding of issues relating to OTC drug availability; and how rational treatment decisions are affected by coexisting Rx and OTC therapies for a particular disease. The announcement is published in the Federal Register April 27



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