The NIH and the FDA announced plans to collaborate on ways to bring innovative products to market sooner, including a joint committee and funding for regulatory development. Innovation and addressing unmet clinical needs were identified as a priority for the CDRH under new director Jeff Shuren.
The two agencies plan to create a Joint Leadership Council, which will focus on encouraging researchers to think about regulatory issues early in the technology development cycle. The council will also work to incorporate the latest scientific data into the FDA review process. NIH Director Francis Collins and FDA Commissioner Margaret Hamburg will co-chair the council, which will also include 12 directors and senior staff members from the NIH and FDA.
Additionally, the NIH-FDA partnership will fund developments in regulatory science, making $6.75 million available over three years to support research that "[provides] new methods, models or technologies that will inform the scientific and regulatory community" on ways of evaluating technologies.
The NIH and FDA will hold a public meeting this spring to solicit comments on the initiative.
