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US FDA-EMA QbD Harmonisation Pilot Progressing Slowly

Dispatches from DIA

US FDA-EMA QbD Harmonisation Pilot Progressing Slowly

By Zachary Brennan

The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.

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