FDA, NIH Unveils Initiative To Accelerate Scientific Breakthrough

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 to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.

The agencies are expected to establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council will work together 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.

In addition, the NIH and the FDA is also expected to jointly issue a request for applications, making $6.75m available over three years for work in regulatory science.

The agencies said that 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.

Kathleen Sebelius, secretary at HHS, said: “We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years. 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.”

Margaret Hamburg, commissioner of FDA, said: “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. 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 utilise new tools, standards and approaches needed to properly assess the safety, effectiveness and quality of products currently in development or already on the market.”