Endcrine Insider
March 4, 2010

(See Full Issue)

On February 24, Health and Human Services Secretary Kathleen Sebelius joined National Institutes of Health (NIH) Director Francis Collins and U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg on the NIH campus to announce a new partnership between NIH and FDA that is aimed at speeding the process of scientific discovery to new and innovative treatments. Endocrine Society staff were present for the announcement, during which Drs. Collins and Hamburg provided some specifics about the purpose of the joint effort.  The initiative involves two interrelated scientific disciplines, translational science and regulatory science, and is designed to promote closer collaboration between the two agencies at every level.  The vision for the initiative is to establish a system in which regulatory considerations form an integral component of biomedical research planning and that the latest science is integrated into the regulatory review process.

The partnership has three components: formation of a Joint Leadership Council that will comprise senior leadership from the NIH and the FDA, allocation of $6.75 million over three years that will be used to support regulatory science research, and engagement of the interested public through outreach, including a public meeting this spring to solicit input on how the agencies can work better together.

For more information please click here.