The US Food and Drug Administration (FDA) has partnered with the National Institutes of Health (NIH) to speed up the process whereby biomedical discoveries become therapies available for patients.
The joint initiative will focus on two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments, and regulatory science, which involves the development and use of new tools, standards and approaches to create more efficient and safer products.
The two agencies will set up a Joint NIH-FDA Leadership Council 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.
The agencies will also make $6.75m available over the next three years to help fund regulatory science research.
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