FDA and NIH Collaboration Aims to Speed New Treatments to Patients | Friends of Cancer Research

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FDA and NIH Collaboration Aims to Speed New Treatments to Patients

On February 23, 2010,  FDA Commissioner Dr. Margaret Hamburg, NIH Director Dr. Francis Collins, and Secretary of Health and Human Services Kathleen Sebelius announced an initiative designed to accelerate the process to get scientific breakthroughs to patients.

(L-R) Dr. Hamburg, Dr. Sigal, Secretary Sebelius, Dr. Collins meet before announcement

"This initiative is an important step toward much-needed increased interagencey collaboration. The advancement of regulatory science at FDA is critical to ensure the safety and efficacy of new drugs and to foster the innovation of new therapies," said Dr. Ellen Sigal, Chair and Founder of Friends. "Without collaboration, and the development of regulatory science programs, the full potential of biomedical research may be stifled."

The initiative involves two interrelated scientific disciplines:

Translational Science: the shaping of basic scientific discoveries into treatments

Regulatory Science: 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.

Both disciplines are vital to turn biomedical discoveries into products that can help patients fighting diseases like cancer.
NIH-FDA Leadership Council
As part of the effort, the agencies will establish a joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The 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.
RFA- $6.75 Million
In addition, the NIH and the FDA will jointly issue a RFA, making $6.75 million dollars available over three years for work on regulatory science. The research supported through this initiative aims to add to the scientific base by providing new methods, models and technologies that will inform the scientific community about better approaches to evaluating safety and efficacy of medical product development.
This new initiative will rely on the NIH's expertise in supporting and facilitating new discoveries in the lab, and the FDA's experience and knowledge in the regulation and approval of drugs, biologics and  devices.
The FDA and the NIH will hold a public meeting in the spring to solicit input on how the agencies can work better together.
For more information on Regulatory Science at FDA: CLICK HERE