The U.S. Food and Drug Administration and the National Institutes of Health unveiled an initiative designed to speed the development of scientific breakthrough to innovative medical therapies for patients. The initiative involves two interrelated scientific disciplines: translational science and regulatory science. Both disciplines are needed to turn biomedical discoveries into products that benefit people.

 

As part of the effort, the agencies will establish a joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues 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. The agencies will also contribute nearly $6.8 million over the next three years for regulatory research grants.

 

“We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years,” says U.S. Health and Human Services Secretary Kathleen Sebelius. “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 effort will rely on the NIH's experience supporting and facilitating new discoveries in the laboratory and clinic and the FDA's more than 100 years of experience and knowledge in the regulation and approval of drugs, biologics and medical devices.

 

“The FDA plays an essential and unique role in how therapies are evaluated. We are the bridge between biomedical research discoveries and new medical products,” says  Margaret Hamburg, FDA commissioner. “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.”