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In Brief

This article was originally published in The Gold Sheet

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Executive Summary

It’s time to comment on ICH Q11

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Regulators Closer to Harmonizing QbD Review Approaches Under Pilot

Regulators in the U.S. and Europe are a little closer to harmonizing their reviews of new drug applications containing QbD elements under a joint review program. Areas of agreement include what is meant by QTPP and criticality, while areas of disagreement include NIR methods and design space development.

Industry, Regulators Divided Over Q11 Definition of API Starting Materials

Drug Shortages Are A Matter Of Time As Bill Sponsors Work To Show Warnings Will Help

Supporters of pending legislation on drug shortages face a challenge of time – demonstrating that the extra time the advance-warning system would provide is worth the legislative time and effort to create it.

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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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