American Association for Cancer Research

AACR CANCER POLICY MONITOR

CPM

                                                                                                          MARCH 2010

NIH-FDA INITIATIVE TO SPEED SCIENTIFIC BREAKTHROUGHS TO PATIENTS

New collaboration will better integrate science into the regulatory review process

The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are working together on a new endeavor to accelerate scientific innovation into effective treatments for patients.  

The collaboration will harness the expertise of each agency and take steps to drive better integration of regulatory consideration into biomedical research planning to ensure that the latest science is incorporated with the regulatory review process. A Joint NIH-FDA Leadership Council, co-chaired by the agency directors and composed of six senior scientists from each agency, will oversee the initiative.

The NIH and the FDA will jointly issue a Request for Applications, making $6.75 million dollars available over three years to fund two- to three-year grants for the development of tools for regulators to assess the risks and benefits of therapies.

"This collaboration is the first of its kind and will use the NIH’s breadth of experience as a leader in biomedical sciences, to help make the regulatory review process at the FDA as seamless as possible," said NIH Director Francis S. Collins, M.D., Ph.D.

Dr. Collins joined Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, and Kathleen Sebelius, secretary of the Department of Health and Human Services (HHS), at a press conference in Washington, D.C., to unveil the new partnership on Feb. 24. A public meeting will be convened this spring to solicit input on how the agencies can best move forward.

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