Parekh A, Buckman-Garner S, McCune S, ONeill R, Geanacopoulos M, Amur S, Clingman C, Barratt R, Rocca M, Hills I, Woodcock J
Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2015 Mar;97(3):221-33. doi: 10.1002/cpt.42. Epub 2015 Jan 28.
The US Food and Drug Administration (FDA) has directed considerable effort towards modernizing its regulatory processes over the past decade to address the challenges in the drug development sector. Through partnerships and input from stakeholders, multiple initiatives are under way, many projects have been launched, several have resulted in tangible results, and many are ongoing and under discussion. We are learning that collaborative efforts can better inform and leverage existing knowledge, that the challenges of data sharing and intellectual property can be overcome, and that there is wide interest in partnering to address key public health regulatory science issues. It is crucial that we continue to build on these initial efforts to facilitate drug development.
在过去十年中，美国食品药品监督管理局（FDA）投入了大量精力来实现其监管流程的现代化，以应对药物研发领域的挑战。通过与利益相关者建立伙伴关系并听取他们的意见，多项举措正在推进，许多项目已经启动，一些已取得切实成果，还有许多项目正在进行中且仍在讨论。我们逐渐认识到，合作努力能够更好地提供信息并利用现有知识，数据共享和知识产权方面的挑战是可以克服的，而且各方对通过合作解决关键的公共卫生监管科学问题有着广泛的兴趣。至关重要的是，我们要在这些初步努力的基础上继续前进，以促进药物研发。
