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Regulators Closer to Harmonizing QbD Review Approaches Under Pilot

This article was originally published in The Gold Sheet

Executive Summary

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.

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