FDA, NIH to fast-track med-tech innovation

The Food & Drug Administration and the National Institutes of Health launched a new program aimed at speeding innovative medical technologies to market.

The joint program involves translational science, “the shaping of basic scientific discoveries into treatments,” and regulatory science, or “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,” according to a press release.

The two agencies will create a Joint NIH-FDA Leadership Council to lead the initiative “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,” according to the release.

The program will also provide $6.75 million over three years for regulatory science research on 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,” Health and Human Services Dept. secretary Kathleen Sebelius said in prepared remarks. “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.”

The agencies are planning a public meeting this spring to gather input on how the federal watchdog and the national research organization can best work together.

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