The U.S. Food and Drug Administration and the National Institutes of Health unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.
The initiative, announced in a press release Feb. 24, 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 said.
The Joint NIH-FDA Leadership Council will work 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 will jointly issue a Request for Applications, making $6.75 million available 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 that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development.
"For more than two decades, the NIH and the FDA have been partners in multiple health initiatives designed to improve the health of millions of Americans,” said Francis S. Collins, the NIH’s director. "This collaboration, however, is the first of its kind and will use the NIH’s breadth of experience as a leader in biomedical sciences, to help make the regulatory review process at the FDA as seamless as possible."
The FDA and the NIH will hold a public meeting in the spring to solicit input on how the agencies can work better together.