The need for enhanced collaboration between NIH and FDA has never been more pressing, given new scientific opportunities in translational research, new public health challenges, far-reaching economic changes at the national and global level, and fundamental changes to the U.S. health care system. The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) share a common goal of advancing public health by promoting the translation of basic and clinical research findings into medical products and therapies. The agencies are complementary in their roles and functions—NIH supports and conducts biomedical and behavioral research and FDA ensures the safety and effectiveness of medical and other products.
The Joint Leadership Council works together 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. Such collaboration and integration advances the development of new products for the treatment, diagnosis, and prevention of common and rare diseases and enhances the safety, quality, and efficiency of the clinical research and medical product approval enterprise. The formation of the Leadership Council represents a commitment on the part of both agencies to forge a new partnership and to leverage the strengths of each agency toward this common goal.
Structure and Process
The Leadership Council is composed of the heads and selected senior leadership of each agency. In addition to plenary meetings of the full Council, work is carried out in individual working groups that are developed and maintained, when needed, to support short-term, intermediate, or long-term projects.
The Leadership Council is chaired by the NIH Director and FDA Commissioner. As shown in the NIH FDA Joint Leadership Council Roster, seven members are chosen by NIH from among the NIH Institute and Center Directors and senior staff, and seven members are chosen from among FDA's Center Directors and senior staff.
Meetings and Management
Meetings of the Leadership Council are held at the request of the Chairs. Working Groups meet on an as needed basis as defined by the WG chairs. Management and support services are provided by the Office of Biotechnology Activities in the Office of the Director, NIH, working with FDA's Office of the Chief Scientist.