Building a National Framework for the Establishment of Regulatory Science for Drug Development Workshop Summary (2011) / Chapter Skim
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7 Envisioning Successful Regulatory Science at FDA
7 Envisioning Successful Regulatory Science at FDA
Pages 45-48
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He described ideal circumstances in which product development, treatments for rare diseases, regenerative medicine, predictive medicine, and infor 1 This section is based on the presentation of Jesse Goodman, Chief Scientist and Deputy Commissioner for Science and Public Health, FDA.
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From page 46... ...
An ideal regulatory system will be able to identify innovative products with the potential to address unmet medical needs and provide countermeasures for public health and stability. • ocus on regenerative medicine -- Stem cells, engineered tissues, F and combination products are areas of rapidly emerging technol ogy; however, FDA's intervention will be necessary to bridge the gap between innovation and the market.
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From page 47... ...
In part nership with the health care sector and community settings, the knowledge derived through informatics could result in optimized outcomes, clinical trials, and patient safety and ultimately speed up product development. Finally, Goodman suggested that methods for resolving scientific disputes internally and externally are needed to match the rapid pace of research.
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