Abstract

In 2004, the US Food and Drug Administration (FDA) launched its Critical Path Initiative. Recognizing the increasingly complicated and difficult path to medical product development, the FDA concluded that it was very important to develop new tools to evaluate and predict the safety, efficacy and manufacturability of medical products. The FDA called for a national effort to identify specific activities all along the critical path of medical product development and use, which, if undertaken, would help transform the critical path sciences.

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