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The "Critical Path" is the scientific process through which a potential pharmaceutical, or medical device is transformed from a discovery into a medical product. Along the critical path, scientific tests and tools are used to predict whether a product candidate will be safe and effective, to assess how prototypes interact with the human body, and to guide the sponsor in choosing an appropriate dose and regimen or device size and/or placement. To bring a product to market successfully and efficiently, product sponsors need scientifically sound approaches.

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The Food and Drug Administration's (FDA) Critical Path Initiative and subsequent guidance documents have sparked the revitalization of the life sciences industry.

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The EMEA's guidance is a roadmap for understanding current and future guidelines.

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It's hard to argue with the basic premise of the FDA's Critical Path Initiative-to help the flow of medical products through the development pipeline.

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The Critical Path Initiative (CPI), as it has come to be called, provided the FDA's analysis of the current drug development pipeline problem, characterized by a recent slowdown-instead of the expected acceleration-in innovative medical therapies reaching patients.

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In March 2004, FDA issued a provocative white paper: Innovation and Stagnation-Challenge and Opportunity on the Critical Path to New Medical Products. The Critical Path was identified by FDA as those parts of the R&D continuum that constitute bottlenecks in the drug development process.

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Scientific discovery is, by its very nature, plagued by a lag between concept development and the acquisition of the tools necessary to fully explore a new technology's application.

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The FDA's Critical Path Initiative acknowledges long-standing and widely accepted challenges facing the clinical research enterprise and identifies several opportunity areas that may help to address these challenges.

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European law now gives prominence to the suitability of investigators and the quality of facilities, two important clinical trial issues.

For the EU, these new good clinical practice rules come not from Brussels, but Mt. Sinai.