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Draft III.Regulatory Innovation and Advancement of Regulatory Science A very significant barrier to participation of capable large pharmaceutical firms in the development of countermeasures against public health threats is the complex, time-consuming, and uncertain path to approval. Novel countermeasures for public health threats face all of the challenges associated with traditional drug development plus the uncertainties associated with diseases that are difficult to study and the complexities of the FDA "animal rule" pathway to product approval. These uncertainties, and the challenges of developing suitable animal models (or alternative paths to approval), have created conditions of intolerable risk for pharmaceutical companies where biodefense and other public health products are concerned. These challenges can be addressed in two ways, by advancing the regulatory science that governs the approval process and by ensuring that FDA has the resources and staff to be more responsive and accessible to industry partners at every stage of the development process. Modernizing and streamlining our regulatory process to create pathways to approval that are more predictable, transparent, and rapid than currently exist is an indispensable condition of participation for large pharmaceutical firms. The best way to map out such pathways is collaboratively, in particular by advancing the emerging field of regulatory science. Working with industry partners to improve the efficiency of product development and evaluation, while simultaneously enhancing regulators' confidence in the safety and effectiveness of regulated products, will facilitate the path to approval, thereby reducing cost, risk, and uncertainty for our partners and accelerating the delivery of the medical countermeasures that we need. This type of close interaction, beginning very early in product development and continuing through and after approval, is of tremendous value to industry and a proven ingredient in those public health product development efforts that have been successful to date. In addition to smoothing the path to approval, such an approach identifies scientific gaps and potential product problems early, allowing them to be addressed more efficiently and effectively, or, if needed, supporting a need to change course. To generate much-needed advancements in regulatory science, the FDA will establish and manage a regulatory science center. This program will evolve, evaluate, and validate new tools and practices that can facilitate biomedical product development, evaluation and manufacturing. The center will also examine and make recommendations for changes of regulatory policies where there is an opportunity to improve simplicity, transparency, speed, and effectiveness of regulatory oversight. The FDA program will directly engage with the partnerships described in the section above to create opportunities to explore solutions that assist FDA and industry in improving speed and effectiveness in regulatory testing and evaluation. Pharmaceutical firms will be offered the opportunity to collaborate with each other and directly with FDA staff to address regulatory problems of common concern, advance regulatory science, and promote regulatory evolution. FDA will benefit by building core expertise in new regulatory technologies, predictive models, and approaches to statistical analysis. FDA and industry will both benefit from the earlier introduction of novel ideas and practices for regulatory scrutiny and troubleshooting. Finally, and most importantly, the public will benefit from the introduction of new technology into the medical product development process that lowers the time and cost of development, while simultaneously improving the quality of safety and efficacy assessment.