FDA and NIH establish joint council for medical therapy advancement
The FDA and the National Institutes of Health (NIH) have announced a collaborative effort in which the agencies will establish a Joint NIH-FDA Leadership Council to work on important public health issues, further scientific efforts and make innovative medical therapies available to patients, said the agencies.

Two scientific disciplines will be involved in the initiative: translational science--the shaping of basic scientific discoveries into treatment--and regulatory science, which is the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality.

According to the agencies, the joint council will mutually issue a request for applications, which will make available $6.75 million over the course of three years for work in regulatory science.  In addition, the agencies 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.

Both the FDA and the NIH believe that this initiative will inform the scientific and regulatory community on improved approaches in the evaluation of safety and efficacy in medical product development.

Slated for spring 2010, a public meeting to solicit input on how the agencies can better work together will be held by the FDA and the NIH, said the agencies.