This article was originally published in The Gold Sheet
It’s time to comment on ICH Q11
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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.
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.