美國食品和藥品管理局（FDA）正在就2011-2015戰(zhàn)略重點(diǎn)草案征求公眾的評(píng)議意見。FDA已經(jīng)確定了這些戰(zhàn)略重點(diǎn)和目標(biāo)，認(rèn)為將會(huì)引導(dǎo)其努力實(shí)現(xiàn)公眾健康的使命。FDA正在征求公眾意見，以幫助進(jìn)一步完善這些重點(diǎn)和目標(biāo)，電子評(píng)議意見應(yīng)提交到www.regulations.gov.
該文件顯示FDA未來5年的首要工作重點(diǎn)是在加強(qiáng)執(zhí)法活動(dòng)的同時(shí)完善FDA的科學(xué)專業(yè)技能和監(jiān)管工具。FDA共確定了4大工作重點(diǎn)：推進(jìn)科學(xué)監(jiān)管與創(chuàng)新；鞏固全球供應(yīng)鏈；加強(qiáng)執(zhí)法守法活動(dòng)；以及解決尚未滿足的公共衛(wèi)生需求。
FDA將制定一項(xiàng)戰(zhàn)略計(jì)劃以拓展科學(xué)監(jiān)管領(lǐng)域并實(shí)現(xiàn)該領(lǐng)域的現(xiàn)代化，這項(xiàng)計(jì)劃將在FDA內(nèi)部以及全國范圍內(nèi)推行。FDA表示，進(jìn)一步完善監(jiān)管技巧、工具和標(biāo)準(zhǔn)將使產(chǎn)品評(píng)審工作更加準(zhǔn)確也更加高效，還將減少上市后安全性問題并能使新技術(shù)迅速投放市場。
科學(xué)監(jiān)管計(jì)劃將有助于FDA針對那些可以解決尚未滿足的公共衛(wèi)生需求的產(chǎn)品制定相應(yīng)的標(biāo)準(zhǔn)，并能引入個(gè)性化醫(yī)療、干細(xì)胞治療以及基因診斷等領(lǐng)域的新進(jìn)展。
FDA還將致力于進(jìn)一步加強(qiáng)執(zhí)法和守法活動(dòng)。
這份報(bào)告稱：“FDA必須果斷而迅速地確保執(zhí)法活動(dòng)的有效性。”除了去年開展的執(zhí)法行動(dòng)之外，F(xiàn)DA還將啟動(dòng)具體的實(shí)施程序以便FDA在發(fā)出警告信、決定大規(guī)模召回或采取了其他執(zhí)法行動(dòng)之后優(yōu)先開展追蹤調(diào)查。FDA還將與其各個(gè)現(xiàn)場辦公室、地方和國家監(jiān)管機(jī)構(gòu)以及外國政府開展更加密切的合作，共享更多的實(shí)驗(yàn)室和執(zhí)法數(shù)據(jù)。
該草案的目錄如下：
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
相關(guān)文件：2011-2015戰(zhàn)略重點(diǎn)(PDF – 391KB)
新聞原文：http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm227527.htm
