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FDA Forced OTC Switch Process Ambiguities Revealed At Subcmte. Hearing

This article was originally published in The Tan Sheet

Executive Summary

FDA does not have an established procedure in place to prevent the disclosure of protected trade secrets in the event of a forced Rx-to-OTC switch, Center for Drug Evaluation & Research Director Janet Woodcock, MD, told a House panel June 13.

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Antihistamine Forced Switch Proposal Returns In Citizen Petition

A law firm seeks to cut its own health care costs as well as direct FDA's attention to previous citizen petitions to switch Rx antihistamines to OTC with a petition asking FDA to switch Sanofi-Aventis's Allegra and Pfizer's Zyrtec

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