FDA and NIH are working together on an initiative that involves two interrelated scientific disciplines. These disciplines include translational science to shape basic scientific discoveries into treatments and regulatory science to develop new tools, standards, products, and evaluate product safety, efficacy, and quality.
“FDA plays an essential and unique role in how therapies are evaluated. We are the bridge between biomedical research discoveries and new medical products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs.
As part of the effort, the agencies will establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Council will work together to ensure that regulatory considerations are an integral part of biomedical research planning and that the latest activities in science are integrated into the regulatory review process.
In addition, NIH and FDA will jointly issue a Request for Applications to provide $6.75 million over three 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 so that the scientific and regulatory community can find better approaches to evaluating safety and efficacy in medical product development.