Digestive Diseases News Summer 2010
NIH and FDA Announce Partnership to Speed New Treatments to Patients
The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have launched an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. The collaboration combines the NIH’s vast experience supporting and facilitating new discoveries in the laboratory and clinic with the FDA’s more than 100 years of experience and knowledge in the regulation and approval of drugs, biologics, and medical devices.
The initiative 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 more effectively evaluate product safety, efficacy, and quality. Both disciplines are needed to turn biomedical discoveries into safe and beneficial treatments.
The agencies will establish a Joint NIH–FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council’s work will 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.
In addition, the NIH and the FDA will jointly issue a Request for Applications, making $6.75 million available over 3 years for work in regulatory science. The research supported through this initiative should add to the scientific knowledge base by providing new methods, models, or technologies that will inform the scientific and regulatory community about better approaches to 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 U.S. Department of Health and Human Services Secretary Kathleen Sebelius, who announced the initiative on February 24, 2010. “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 to foster access to the safest and most effective therapies for the American people.”
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NIH Publication No. 10–4552
August 2010
