Diabetes Dateline
Summer 2010
NIH and FDA Announce Partnership to Speed
New Treatments to Patients
The U.S. Food and Drug Administration (FDA)
and the National Institutes of Health (NIH) have
launched an initiative designed to accelerate the process
from scientific breakthrough to the availability of new,
innovative medical therapies for patients. The collaboration
combines the NIH’s vast experience supporting and facilitating
new discoveries in the laboratory and clinic with the FDA’s
more than 100 years of experience and knowledge in the regulation
and approval of drugs, biologics, and medical devices.
The initiative involves two interrelated scientific
disciplines: translational science, the shaping of
basic scientific discoveries into treatments, and
regulatory science, the development and use of
new tools, standards, and approaches to more
efficiently develop products and more effectively
evaluate product safety, efficacy, and quality.
Both disciplines are needed to turn biomedical
discoveries into safe and beneficial treatments.
The agencies will establish a Joint NIH–FDA
Leadership Council to spearhead collaborative
work on important public health issues. The
Joint Leadership Council’s work 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.
In addition, the NIH and the FDA will jointly
issue a Request for Applications, making
$6.75 million available over 3 years for work
in regulatory science. The research supported
through this initiative should add to the scientific
knowledge base by providing new methods,
models, or technologies that will inform the
scientific and regulatory community about better
approaches to evaluating safety and efficacy in
medical product development.
“We’ve all been following the remarkable
advances in biomedical sciences led by the
NIH with great enthusiasm for years,” said U.S.
Department of Health and Human Services
Secretary Kathleen Sebelius, who announced the
initiative on February 24, 2010. “However, much
more can be done to speed the progress from new
scientific discoveries to treatments for patients.
Collaboration between NIH and FDA, including
support for regulatory science, will go a long way
to foster access to the safest and most effective
therapies for the American people.”
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NIH Publication No. 10–4562
August 2010
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