2012 年监管科学改革：发挥作用。

Transforming regulatory science 2012: making a difference.

机构信息

Office of the Chief Scientist/Office of the Commissioner, US Food and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland, USA.

出版信息

Clin Pharmacol Ther. 2012 Mar;91(3):375-7. doi: 10.1038/clpt.2011.329.

DOI:10.1038/clpt.2011.329

PMID:22343811

Abstract

"What does not change is the will to change."-Charles Olson, "The Kingfishers"The world is in the midst of scientific revolutions that can transform medicine and public health. Yet translation to needed products remains slow and expensive. There are major opportunities for new regulatory science to help transform product development and evaluation. A plan by the US Food and Drug Administration (FDA), "Advancing Regulatory Science," identifies eight priorities and numerous actions to help catalyze transformation. Scientific excellence and collaboration, including public and private sectors, are essential for change that benefits health and economies globally.

摘要

“不变的是改变的意愿。”-查尔斯·奥尔森，《鱼鹰》

世界正处于可以改变医学和公共卫生的科学革命之中。然而，将其转化为所需的产品仍然缓慢且昂贵。新的监管科学有很大的机会帮助改变产品开发和评估。美国食品和药物管理局（FDA）的一项名为“推进监管科学”的计划确定了八项优先事项和许多行动，以帮助推动变革。卓越的科学和合作，包括公共和私营部门，对于有益于全球健康和经济的变革至关重要。