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FDA Rx-To-OTC MaPP On Course For Release In 2005

This article was originally published in The Tan Sheet

Executive Summary

A revised version of FDA's Manual of Policies and Procedures for Rx-to-OTC switch proposals is scheduled to come out by the fall of 2005

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Director of the Office of Nonprescription Products Charles Ganley, MD, and Assistant Director Susan Johnson, PhD, met with industry stakeholders at a conference Feb. 1 to present an overview of the status of ONP in 2006. The department heads discussed FDA's plans to set a final deadline on monograph clearance and improve internal communication and NDA review, and made several suggestions on how industry can help FDA do its job..

ONP: Leaner, Meaner In 2006

Director of the Office of Nonprescription Products Charles Ganley, MD, and Assistant Director Susan Johnson, PhD, met with industry stakeholders at a conference Feb. 1 to present an overview of the status of ONP in 2006. The department heads discussed FDA's plans to set a final deadline on monograph clearance and improve internal communication and NDA review, and made several suggestions on how industry can help FDA do its job..

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Director of the Office of Nonprescription Products Charles Ganley, MD, and Assistant Director Susan Johnson, PhD, met with industry stakeholders at a conference Feb. 1 to present an overview of the status of ONP in 2006. The department heads discussed FDA's plans to set a final deadline on monograph clearance and improve internal communication and NDA review, and made several suggestions on how industry can help FDA do its job..

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