Critical Path Initiative
The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or "proof of concept" into a medical product. This effort is particularly important for Parkinson’s disease because of the lengthy development and approval times for central nervous system drug therapies.
The Critical Path Initiative grew out of the FDA’s investigation into the downward trend in applications for drugs, biologics and medical devices. The FDA concluded that reversing the decrease in applications would require modernization of the medical product development process – the Critical Path – to make product development more predictable and less costly.
The Critical Path Initiative has the opportunity to be an important step toward realizing the promise of personalized medicine: getting the right medicine to the right patient, at the right time, and in the right dosage. Under the auspices of Critical Path, FDA and stakeholders will work together to develop the tools necessary to usher in the new era of personalized medicine, such as new validated safety and efficacy biomarkers and new ways to measure variation in patient responses.
PAN endorsed this Initiative in January 2006 by sending a letter of support to the Secretary of Health and Human Services. PAN joined 21 other organizations and coalitions on the letter. Read the letter of support.
Read more about the Critical Path Initiative on the FDA’s dedicated website: http://www.fda.gov/oc/initiatives/criticalpath/
Read Janet Woodcock's,
Deputy Commissioner and Chief Medical Officer for the FDA, Commentary on the Critical Path Initiative: http://www.fda.gov/oc/initiatives/criticalpath/commentary.html
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