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In Brief: Rx-to-OTC switch applications

This article was originally published in The Tan Sheet

Executive Summary

Rx-to-OTC switch applications: Representatives from FDA's Center for Drug Evaluation and Research told PhRMA board members Feb. 8 that the agency's internal reform efforts include developing written procedures for OTC switches. In a section-by-section analysis of draft FDA reform legislation circulated last summer, PhRMA pointed out the confusion at FDA prior to the creation of the now defunct Office of OTC Drug Evaluation regarding authority over Rx-to-OTC switch applications ("The Tan Sheet" July 17, 1995, p. 23). PhRMA's original draft legislation for FDA reform included a provision that would have retained office status for OTC drugs...





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