• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Science & Research

  • Print
  • Share
  • E-mail

FDA-NIH Joint Leadership Council Charter

Purpose

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 the prospect of fundamental changes to the U.S. healthcare 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.

Function

The Joint Leadership Council will work 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 will advance the development of new products for the treatment, diagnosis and prevention of common and rare diseases and enhance 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 will be composed of the heads and selected senior leadership of each agency. In addition to plenary meetings of the full Council, work will be carried out in individual working groups that will be developed and maintained, when needed, to support short-term, intermediate or long-term projects.

Membership

The Leadership Council will be chaired by the NIH Director and FDA Commissioner. Six members will be named by NIH from among the NIH Institute and Center Directors and Senior Staff, and six members will be named from among the FDA Center Directors and Senior Staff.

Meetings and Management

Meetings of the Leadership Council will be held at the request of the Chairs. Working Groups will meet on an as needed basis as defined by the WG chairs. Management and support services will be provided by the Office of Biotechnology Activities in the Office of the Director, NIH working with the Office of the Chief Scientist at FDA.