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Akron Univ. School of Law

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Monday, March 1, 2010

FDA and NIH Collaborate to Promote Regulatory Science

The LA Times reports that the Food and Drug Administration and the National Institutes of Health have announced a partnership to collaborate on regulating new products and procedures that arise out of advanced research. Together, the NIH and FDA will make at total of $6.75 million in grants for regulatory science research over a three-year period.

The new partnership will promote the development of testing and other tools that FDA regulators need in order to assess drugs and other products coming from fields such as genomics, nanotechnology and stem cell therapy. Officials from both agencies said laboratory science leading to treatments had vastly outdistanced regulatory science, which develops the methods to evaluate the safety and quality of those treatments.

FDA Commissioner Margaret Hamburg compared the imbalance to the arms of a rower. "We have allowed the arm of regulatory science to become weak and underdeveloped," Hamburg said at a news briefing. If not corrected, "instead of pulling us into an exalted future, we will row in circles."

The NIH-FDA collaboration includes the formation of a six-member council of top scientists from both agencies to make sure that the latest science is incorporated into the regulatory review process.

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