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Critical Path Opportunities Report
It’s no secret that FDA regulations contribute to the onerous and expensive process of bringing new medicines and medical devices onto the market. The challenge is in deciding which regulations contribute to public health and safety, and which may, in fact, be acting as a barrier to medical progress.
Industry, for its part, also needs to adapt a more collaborative stance with regulators and become more proactive in sharing information that can be used to develop industry-wide benchmarks for testing the safety and efficacy of potential new products.
In recognition of these challenges, in 2004 the FDA reached out to stakeholders and the academic community to create a Critical Path Initiative designed to produce a new scientific “toolkit” that will not only streamline the regulatory approval process but help make new treatments safer and more effective. This week, the FDA produced a new Critical Path Opportunities report and list that it hopes will “bring concrete focus to specific tasks needed to modernize the product development sciences.”
We believe it is critical to build a national infrastructure to support and continually improve the Critical Path sciences. […] Our stakeholders have pointed out that modernizing development science alone is not enough; we must also modernize FDA policies and standards to keep up with the evolving science. We agree with this analysis and will work to ensure that regulatory modernization keeps pace with scientific advances. […] The Critical Path Opportunities List identifies specific opportunities that, if implemented, will increase efficiency, predictability, and productivity in the development of new medical products.
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