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Critical Path Initiative

Four images: Woman looking through microscope, Gloved hands holding test tube, Pills coming down a manufacturing shoot., Doctor holding a baby

Transforming the way FDA-regulated products are developed, evaluated, and manufactured

 About Critical Path

The Critical Path Initiative (CPI) is FDA's national strategy for transforming the way FDA-regulated medical products are developed, evaluated, and manufactured.  The Initiative was launched in March 2004, with the release of FDA's landmark report Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. The publication diagnosed the reasons for the widening gap between scientific discoveries that have unlocked the potential to prevent and cure some of today's biggest killers, such as diabetes, cancer, and Alzheimer's, and their translation into innovative medical treatments. Sounding the alarm on the increasing difficulty and unpredictability of medical product development, the report concluded that collective action was needed to modernize scientific and technical tools as well as harness information technology to evaluate and predict the safety, effectiveness, and manufacturability of medical products.

More: Archived information about the Critical Path program

Critical Path Programs

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