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"<p>The U.S. Food and Drug Administration and the National  Institutes of Health unveiled an initiative designed to accelerate the process  from scientific breakthrough to the availability of new, innovative medical  therapies for patients.</p><br /><p>The initiative, announced in a press release Feb. 24, 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.</p><br /><p>Both disciplines are needed to turn biomedical discoveries into  products that benefit people, the agencies said.</p><br /><p>The Joint NIH-FDA Leadership Council will work 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.</p><br /><p>In addition, the NIH and the FDA will jointly issue a Request  for Applications, making $6.75 million 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.</p><br /><p>&quot;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,&rdquo; said Francis S. Collins, the NIH&rsquo;s director. &quot;This  collaboration, however, is the first of its kind and will use the NIH&rsquo;s breadth  of experience as a leader in biomedical sciences, to help make the regulatory  review process at the FDA as seamless as possible.&quot;</p><br /><p>The FDA and the NIH will hold a public meeting in the spring to  solicit input on how the agencies can work better together.</p>"^^<http://www.w3.org/2001/XMLSchema#string>
<http://vaccinenewsdaily.com/stories/510530777-nih-fda-announce-initiative-to-fast-track-innovations-to-public>