MesotheliomaWeb.Org: Critical Path Initiative
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In 2004, the US Food and Drug Administration (FDA) developed the Critical Path Initiative (CPI). The purpose behind the initiative was to improve how the agency regulates and tests new products. One branch of the initiative had the task of improving how new medications, equipment, and other treatment products were formulated, evaluated and manufactured. The goal of these efforts was to develop better methods of moving new scientific and technological treatment capabilities from the laboratory to the open marketplace.
The FDA released a report, titled "Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products", that addressed the issues confronting the availability of medical technology. The report also recommended several methods of making the latest advancements in treating fatal diseases available to the doctors and patients who needed them. These recommendations were intended to streamline the process of innovation in medical technologies, while still testing the new treatments for safety and efficacy.
Another feature of the report is the “Critical Path Opportunities List”. The list contained several tasks that the agency and the medical research community could undertake to smooth out the development and delivery of new treatment methods. The report recommended ways to ease the process of clinical trials, which would enable manufacturers to deliver their products to the market sooner while still maintaining safety standards.
The report also listed the potential improvement in product evaluation processes as a way to get treatments to patients in a shorter time frame. The list also included updates in the procedures commonly used to manufacture pharmaceuticals and other medical products in its recommendations. Technological improvements often contribute to smoother and cheaper manufacturing processes. Innovations in manufacturing would also lower product costs and make the products available to a wider range of customers.
In just a few years, the CPI has already improved much of the process that takes medical innovations from ideas to reality. When the report was released in 2006, forty medical products were in the testing stages in FDA labs. Three years later, that number increased to ninety-five. By the end of 2010, the number is expected to be well over a hundred. As more researchers and product developers follow the CPI recommendations, the number of new treatment methods will continue to rise.
The processes listed in the report have also led to more cooperation between the FDA and other government agencies, as well as private and public research concerns, to insure that new medical technologies reach the public safely, quickly and effectively. These groups are also working in the new science of bioinformatics, a discipline that combines biological science with information technology, to develop testing methods for new products.
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