The FDA and the NIH are establishing an initiative designed to accelerate the development of drugs based on new scientific breakthroughs. The program encompasses translational medicine and regulatory science.
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 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 together issue a Request for Applications, making $6.75 million available over three years for work in regulatory science. The research supported through this initiative is expected to provide new methods, models, and technologies that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development.
“We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years,” remarks HHS 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.”