The NIH and FDA announced a partnership intended to promote regulatory science to develop tools, standards, and processes for assessing the safety and efficacy of new medical treatments and devices.
The goals of the partnership are to:
1. help ensure that regulatory considerations form an integral component of biomedical research planning;
2. ensure that the latest science is integrated into the regulatory review process;
3. help scientists better understand how they can plan research projects designed to meet FDA evaluation standards; and
4. help the FDA understand the best way to evaluate treatments.
The partnership will form a Council comprised of senior leadership at NIH and FDA. A public outreach meeting will be scheduled in the spring. Additionally, a $6.75 million RFA to support research on regulatory science hopes to fund 2-4 three year research grants. View the RFA, "Advancing Regulatory Science through Novel Research and Science Based Technologies (U01)," at: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-10-006.html