Critical Path Initiative

--Advancing Regulatory Science 

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What's New

• Critical Path Initiative 2010 Update -- Q's and A's
• FDA/NIH Collaborative Initiative to Fast Track Innovations to Public
• Draft guidances for industry issued as part of CPI drive to Streamline Clinical Trials
  • Adaptive Design: Clinical Trials for Drugs and Biologics
  • Non-Inferiority Clinical Trials

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About Critical Path

The Critical Path Initiative (CPI) is FDA's national strategy for transforming the way FDA-regulated products are developed, evaluated, manufactured, and used.  More

Spotlight on Critical Path Projects

• Adaptive Design: Clinical Trials for Drugs and Biologics - New
• Non-Inferiority Clinical Trials - New
• FDA's Sentinel Initiative--Developing active postmarket safety monitoring 
• Critical Path Drives Unique Collaboration to Study Dual Antiplatelet Therapy- New 
• Clinical Trials Transformation Initiative 
• FDA Clinical Investigator Training Course - New
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Critical Path Reports

• Critical Path Annual Report 2008
• FDA's Sentinel Initiative Report
• Critical Path Opportunities Initiated During 2007
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Critical Path Podcasts

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