Two federal agencies today announced a new initiative to support regulatory science, tools and standards used to evaluate new drugs and devices. The National Institutes of Health and the US Food and Drug Administration say they are joining forces to build support for an area that FDA believes is neglected.
Today, on the NIH campus in Bethesda, Maryland, officials have announced that the NIH Director Francis Collins called "an unprecedented effort ... to catalyze the development of new therapies." part of the initiative is a grant program funded up to $ 6.75 million over 3 years, $ 6 million of it from the NIH common Fund, a pot of money to transversal projects. the request of the NIH proposal lists examples from the design of new clinical trials in tools to detect microbial contamination in products.
the other part is a joint council composed of FDA-NIH Collins FDA Commissioner Margaret Hamburg, and other scientists at the agency that will link research and regulatory review process. It is still to define its program and request comments from patient advocates and others during a public meeting this spring, said Collins.
The initiative comes in addition to a proposed $ 25 million for regulatory science in the 2011 budget for the FDA to nanotechnology and other fields. Hamburg said that "there are elements of integrated regulatory science in all aspects of what we do," but this is the first FDA "targeted initiative."
The FDA has already a 6 years program, the critical path Initiative, which, according to its website, is funding a number of research projects on topics such as the design of the clinical trial. But Collins said his main component of the research institute in Arizona, is "modest in size." he admits that $ 6.75 million-enough for only two or three price is modest, too. But it could grow, he said, according to the interest of scientists.
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