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FDA Issues OTC “Time & Extent” Application Draft Guidance

This article was originally published in The Tan Sheet

Executive Summary

Time and extent applications for OTC monograph eligibility should describe adverse event reporting systems in countries outside the U.S. where active ingredients have been marketed, according to an FDA draft guidance

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FDA should consider making a voluntary fee option for expedited reviews of OTC monograph time and extent applications, Ciba Specialty Chemicals recommends in April 13 comments to the agency

TEA Fee For Expedited Review Option, Dedicated Staff Increase Suggested

FDA should consider making a voluntary fee option for expedited reviews of OTC monograph time and extent applications, Ciba Specialty Chemicals recommends in April 13 comments to the agency

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