Regulatory Update

Posted 01 May 2011 | By Michael Matthews 

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a voluntary 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. QbD in pharmaceuticals involves designing and developing formulations and manufacturing processes to help ensure product manufacturing quality.

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