WASHINGTON, Feb. 24 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.
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.
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.
The effort will rely on the NIH’s vast 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.
“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 NIH Director Francis S. Collins, M.D., Ph.D. “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.”
For more information:
About FDA
www.fda.gov
CONTACT: FDA - Karen Riley, +1-301-796-4674, karen.riley@fda.hhs.gov; or
NIH - Calvin Jackson, +1-301-594-8750, cj8e@nih.gov
Web site: http://www.fda.gov//
http://www.nih.gov//
