Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Tufts University, Boston, Massachusetts, USA.
Clin Pharmacol Ther. 2012 Mar;91(3):393-404. doi: 10.1038/clpt.2011.338. Epub 2012 Feb 15.
Sponsors of new drug applications (NDAs) confront a host of uncertainties, one of the more vexing of which is negotiating the differing and inconsistent policies and standards among the various US Food and Drug Administration (FDA) drug review divisions. The FDA faces many challenges as well, internal and external, that confound its efforts to provide a consistent and timely review process. In this article, we examine various input factors, such as the number of regulatory filings, that contribute to fluctuations in the annual FDA workload, as well as output factors, such as NDA approval times, that are often viewed by sponsors as measures of the FDA's performance. Interdivisional differences at the FDA, in both input and output factors as well as other process-related factors, such as issuance of complete response letters, division staff levels, and quality of the sponsor's application, are considered in light of their contribution to the vagaries of the sponsors' experiences with the regulatory process.
新药申请（NDA）的赞助商面临着诸多不确定性，其中一个令人烦恼的问题是要协商处理美国食品和药物管理局（FDA）各个药品审查部门之间存在的不同和不一致的政策和标准。FDA 也面临着许多内部和外部的挑战，这些挑战使其难以提供一致和及时的审查流程。在本文中，我们研究了各种投入因素，如监管备案数量，这些因素导致 FDA 年度工作量的波动，以及输出因素，如 NDA 批准时间，这些因素通常被赞助商视为 FDA 绩效的衡量标准。我们还考虑了 FDA 在投入和产出因素以及其他与流程相关的因素（如完整回复函的发布、部门员工人数以及赞助商申请的质量）方面的部门间差异，这些因素对赞助商在监管流程中的体验的多变性有一定的影响。
