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Consumer OTC Drugs

CTD Submission Voluntary But Recommended, Guidance Says

This article was originally published in The Tan Sheet

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Executive Summary

Common technical document submission will remain voluntary but recommended, according to an August FDA draft guidance entitled "Submitting Marketing Applications According to the ICH-CTD Format - General Considerations."

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ICH Guidance Will Clarify Integrated Safety, Efficacy Summary Submissions

FDA plans to issue a guidance clarifying what firms should include in integrated summaries of safety and efficacy in common technical document submissions

ICH Guidance Will Clarify Integrated Safety, Efficacy Summary Submissions

FDA plans to issue a guidance clarifying what firms should include in integrated summaries of safety and efficacy in common technical document submissions

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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