Science behind NIH and FDA Collaboration

FDA and the National Institutes of Health (NIH) are partnering to accelerate the process from scientific breakthrough to approval of medical innovations.

An initiative announced today involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards, and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy, and quality, FDA reports in a press release on its Web site. Both disciplines are needed to turn biomedical discoveries into products that benefit people, the announcement claims.

The two agencies are forming a Joint NIH-FDA Leadership Council to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process. FDA and NIH will be looking at public health issues.

Under a jointly issued Request for Applications, $6.75 million dollars will be available for more than three years for researching new methods, models, or technologies for evaluating safety and efficacy in medical product development.

"We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years," said HHS Secretary Kathleen Sebelius in the press release. "However, much more can be done to speed the progress from new scientific discoveries to treatments for patients. Collaboration between NIH and FDA, including support for regulatory science, will go a long way towards fostering access to the safest and most effective therapies for the American people."

Added FDA Commissioner Margaret A. Hamburg, M.D.: "FDA plays an essential and unique role in how therapies are evaluated. We are the bridge between biomedical research discoveries and new medical products. We now have a special opportunity--and responsibility--to harness advances in science and technology to support our efforts. We are working in collaboration with the best minds and research institutions available, so that we can better develop and utilize new tools, standards and approaches needed to properly assess the safety, effectiveness and quality of products currently in development or already on the market."

"For more than two decades, the NIH and the FDA have been partners in multiple health initiatives designed to improve the health of millions of Americans,” said NIH Director Francis S. Collins, M.D., Ph.D. "This collaboration, however, is the first of its kind and will use the NIH’s breadth of experience as a leader in biomedical sciences, to help make the regulatory review process at the FDA as seamless as possible."

Stay tuned for announcement of a public meeting in the spring to offer your input on how the agencies can work together.

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