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September 04, 2007Critical Path commentary.A little over three years after it was launched in 2004, Deputy FDA Commissioner and Chief Medical Officer Dr. Janet Woodcock reflects on what the Critical Path Initiative has achieved: Since the initial report, we have broadened our thinking about the Critical Path Initiative to include veterinary medicines, generic drugs, and even foods. For all product areas, the basic idea is to reduce uncertainty about product performance throughout the product life cycle through scientific research. We have set up a large number of collaborations with partners to get this research done, in areas as disparate as drug manufacturing and clinical trial design. Last year, after extensive FDA and public input, we published a list of 76 examples of promising and high-priority projects that we hoped this initiative would foster. (The report is available online at http://www.fda.gov/oc/initiatives/criticalpath/.) A number of these projects have started. Examples include work with the Juvenile Diabetes Research Foundation on standards for an artificial pancreas; a collaboration with Duke University on drug eluting stents; and safety biomarker research with the C-Path Institute’s Predictive Safety Testing Consortium. In all cases, we look to FDA reviewers and scientists to identify the most pressing problems and scientific issues, so that we can recruit partners to help us address them. In many areas, we are building on work that has already been started. Thanks to the efforts of many within FDA – and our partners in academia, the non-profit sector, and industry – the Critical Path initiative is off to a very good start. What is perhaps the most remarkable aspect of this initiative is that our progress to date has been achieved by drawing on existing financial resources, collaborative relationships, and the considerable efforts of many dedicated FDA employees. I hope that our efforts will continue to receive support, because the Critical Path truly holds the potential to usher in a new era of certainty and predictability in the development and performance of products that we regulate. The ultimate beneficiaries of our efforts will be the public that we serve. The FDA has accomplished some signficant progress on the Critical Path agenda on a shoestring budget, but this also begs the question of whether or not another regulatory model might fit the emerging science - i.e., is the FDA the only agency or entity than can validate new scientific standards for, say, biomarkers? Hat tip: Eye on FDA. Posted by Paul Howard at September 4, 2007 12:50 PM CommentsPost a comment |
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