NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public
Partnership Combines Strengths to Speed New Treatments to
Patients
The U.S. Food and Drug Administration and the National Institutes of
Health today unveiled an initiative designed to accelerate the process
from scientific breakthrough to the availability of new, innovative
medical therapies for patients.
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
to more effectively evaluate product safety, efficacy and quality. Both
disciplines are needed to turn biomedical discoveries into products
that benefit people.
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 Joint Leadership 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.
In addition, the NIH and the FDA will jointly issue a Request for
Applications, making $6.75 million dollars available over three 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 HHS
Secretary Kathleen Sebelius. "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 towards fostering access to the safest and
most effective therapies for the American people."
The effort will rely on the NIH’s vast experience supporting and
facilitating new discoveries in the laboratory and clinic and the FDA’s
more than 100 years of experience and knowledge in the regulation and
approval of drugs, biologics and medical devices.
"The FDA plays an essential and unique role in how therapies are
evaluated. We are the bridge between biomedical research discoveries and
new medical products," said Margaret A. Hamburg, M.D., Commissioner of
Food and Drugs. "We now have a special opportunity--and
responsibility--to harness advances in science and technology to support
our efforts. We are working in collaboration with the best minds and
research institutions available, so that we can better develop and
utilize new tools, standards and approaches needed to properly assess
the safety, effectiveness and quality of products currently in
development or already on the market."
"For more than two decades, the NIH and the FDA have been partners in
multiple health initiatives designed to improve the health of millions
of Americans,” said NIH Director Francis S. Collins, M.D., Ph.D. "This
collaboration, however, 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."
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:
The National Institutes of Health (NIH) — The Nation's Medical
Research Agency — includes 27 Institutes and Centers and is a
component of the U.S. Department of Health and Human Services. It is the
primary federal agency for conducting and supporting basic, clinical
and translational medical research, and it investigates the causes,
treatments, and cures for both common and rare diseases. For more
information about NIH and its programs, visit www.nih.gov4.
FDA - NIH NEWS RELEASE
For Immediate Release: Feb. 24, 2010
Media Inquiries: FDA – Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
NIH – Calvin Jackson, 301-594-8750; cj8e@nih.gov
Media Inquiries: FDA – Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
NIH – Calvin Jackson, 301-594-8750; cj8e@nih.gov
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