FDA, EMA announce pilot for parallel assessment of Quality by Design applications

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The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are submitted to both agencies.

More... (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm247332.htm)