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Building a National Framework for the Establishment of Regulatory Science for Drug Development Workshop Summary (2011) / Chapter Skim
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8 Considering Next Steps
Pages 49-52

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From page 49...
... As HHS Deputy Secretary Corr stated: NIH is the world's leader in biomedical research and FDA is the gold standard across the world in the evaluation and approval of drug prod ucts and other medical products. Secretary Sebelius and I are confident that, with the two dedicated leaders we have in Peggy Hamburg, one of the nation's foremost advocates for public health, and in Francis Collins, one of the nation's most distinguished scientists, they will lead us into a new era in which we can promote and protect public health by realizing the promise of science.
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From page 50...
... He outlined the follow ing key implementation steps for first creating an internal support system for a regulatory science infrastructure at the agency: • eadership to strengthen and support science and promote inno L vation at FDA -- Both the Commissioner's Office and leadership at FDA centers are supportive of promoting science and innova tion. There is interest across the agency in multicenter working groups, scientific guidance, and sharing of resources.
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From page 51...
... BuILDINg A FRAMEWORK: THEMES FROM THE WORKSHOP Weak regulatory science is not a problem just for the FDA; it is a shared problem that requires a shared solution. Several workshop participants called for development of a common framework for enhancing regulatory science.
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From page 52...
... Many workshop participants acknowledged that simultaneously developing in-house expertise, taking advantage of available funding mechanisms, and coordinating with external experts will be a massive undertaking. Building a regulatory science infrastructure will require tremendous commitment, resources, and an agreed-upon blueprint to be successful.
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