NIH, FDA to Fast-Track Regulatory Processes

April 2nd, 2010 | Sources: BurrillReport


The Food and Drug Administration and the National Institutes of Health have announced they will collaborate to hasten development and commercialization of biomedical breakthroughs,  an effort that might eventually reduce R & D costs for developers and speed new therapies to the bedside.

NIHmeetsFDAThe project will utilize the NIH’s expertise in supporting biomedical innovation and the FDA’s 100+ year experience in the regulation of drugs, biologics and medical devices.
 “We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years,” says 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 two agencies, both belonging to HHS, plan to establish a Leadership Council that will oversee collaborative work on public health issues, assure that regulatory matters are factored into biomedical research planning and assure that cutting-edge science becomes part of routine regulatory review processes. The agencies will also pony-up about $6.8 million during the next 3 years to support research on the effects of regulation on biomedical innovation.
“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,” FDA commissioner Margaret Hamburg told BurrillReport.

“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.”


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