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FDA's Critical Path Initiative

BayBiotech.NET

FDA launched its Critical Path Initiative (CPI) in March 2004, with the release of a report “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products”. This report highlights the reasons for the widening gap between modern scientific discoveries with a potential to prevent and cure some of today's biggest medical challenges, and their translation into innovative medical treatments. The main reason identified was being Industry’s apprehension to adapt and train to new technologies that might delay launch of the product into the consumer market.
In order to ease out the apprehension, FDA recognized the need for a collective action to modernize the scientific and technical tools and introduced CPI and calls for incorporating specific activities into the medical development path that would help modernize the critical path sciences. CPI has seen the number of its projects grow from 40 in 2006 to 95 in 2009.
FDA is collaborating with other federal agencies, patient groups, academic researchers, industry, and other stakeholders to identify areas with a potential for improvement and to coordinate and develop solutions to overcome scientific hurdles that are impairing the efficiency of developing and evaluating FDA regulated products.
To explore more to find out about FDA’s CPI Opportunity lists, visit the link:
http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ucm076689.htm

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