美国食品和药品管理局（FDA）正在就2011-2015战略重点草案征求公众的评议意见。FDA已经确定了这些战略重点和目标，认为将会引导其努力实现公众健康的使命。FDA正在征求公众意见，以帮助进一步完善这些重点和目标，电子评议意见应提交到www.regulations.gov.
该文件显示FDA未来5年的首要工作重点是在加强执法活动的同时完善FDA的科学专业技能和监管工具。FDA共确定了4大工作重点：推进科学监管与创新；巩固全球供应链；加强执法守法活动；以及解决尚未满足的公共卫生需求。
FDA将制定一项战略计划以拓展科学监管领域并实现该领域的现代化，这项计划将在FDA内部以及全国范围内推行。FDA表示，进一步完善监管技巧、工具和标准将使产品评审工作更加准确也更加高效，还将减少上市后安全性问题并能使新技术迅速投放市场。
科学监管计划将有助于FDA针对那些可以解决尚未满足的公共卫生需求的产品制定相应的标准，并能引入个性化医疗、干细胞治疗以及基因诊断等领域的新进展。
FDA还将致力于进一步加强执法和守法活动。
这份报告称：“FDA必须果断而迅速地确保执法活动的有效性。”除了去年开展的执法行动之外，FDA还将启动具体的实施程序以便FDA在发出警告信、决定大规模召回或采取了其他执法行动之后优先开展追踪调查。FDA还将与其各个现场办公室、地方和国家监管机构以及外国政府开展更加密切的合作，共享更多的实验室和执法数据。
该草案的目录如下：
Message from the Commissioner
1.0 Introduction
1.1 Mission and Vision
1.2 Purpose of This Document
1.3 Guiding Principles
2.0 Cross-Cutting Strategic Priorities
2.1 Advance Regulatory Science and Innovation
2.2 Strengthen the Safety and Integrity of the Global Supply Chain
2.3 Strengthen Compliance and Enforcement Activities to Support Public Health
2.4 Expand Efforts to Meet the Needs of Special Populations
3.0 Strategic Goals and Long-Term Objectives
3.1 Advance Food Safety and Nutrition
3.1.1 Ensure the Safety of the Food Supply from Farm to Table
3.1.2 Promote Healthy Dietary Practices and Nutrition
3.2 Promote Public Health by Advancing the Safety and Effectiveness of Medical Products
3.2.1 Advance Human Drug Safety and Effectiveness
3.2.2 Advance Biologics Safety and Effectiveness
3.2.3 Advance Medical Device Safety and Effectiveness
3.2.4 Advance Animal Drug Safety and Effectiveness
3.3 Establish an Effective Tobacco Regulation, Prevention, and Control Program
3.4 Manage for Organizational Excellence and Accountability
4.0 Implementation
Appendix A: FDA Strategic Goals and Long-Term Objectives Aligned to Draft HHS Strategic Goals and Objectives
Appendix B: Crosswalk of FDA Strategic Goals and Long-Term Objectives with Related Draft Healthy People 2020 Objectives
Appendix C: Crosswalk between FDA's Strategic Planning Documents
List of Figures
Figure 1. FDA Program and Priority Framework
List of Tables
Table 1. Summary of Long-Term Objectives for Food Safety
Table 2. Summary of Long-Term Objectives for Dietary Practices and Nutrition
Table 3. Summary of Long-Term Objectives for Human Drugs
Table 4. Summary of Long-Term Objectives for Biologics
Table 5. Summary of Long-Term Objectives for Medical Devices
Table 6. Summary of Long-Term Objectives for Animal Drugs
Table 7. Summary of Long-Term Objectives for Tobacco
Table 8. Summary of Long-Term Objectives for Operational Excellence and Accountability
相关文件：2011-2015战略重点(PDF – 391KB)
新闻原文：http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm227527.htm
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