U.S. Food and Drug Administration, Office of Generic Drugs, Silver Spring, MD, USA.
U.S. Food and Drug Administration, Office of Generic Drugs, 10903 New Hampshire Avenue, 75-3662, Silver Spring, MD, 20993, USA.
Ther Innov Regul Sci. 2020 Jul;54(4):758-763. doi: 10.1007/s43441-019-00016-2. Epub 2019 Dec 6.
Implementation of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act of 2012 (Generic Drug User Fee Amendments. https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments) successfully allowed the U.S. Food and Drug Administration (FDA) to modernize review of Abbreviated New Drug Applications (ANDAs) with goal dates. The goal of this study was to assess the success of GDUFA I in decreasing ANDA time to approval and the number of review cycles across the five fiscal years of GDUFA I. Results of this study underscore FDA's continuous progress within its generic drug program and highlight the ongoing collaborative communication process between FDA and ANDA applicants that must continue for the timely approval of high-quality, safe, and effective generic drugs for the American public.
《2012 年食品药品管理局安全与创新法案》下的通用药品使用者付费修正案（GDUFA I）的实施（通用药品使用者付费修正案，https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments）成功地使美国食品药品监督管理局（FDA）实现了目标日期下的简化新药申请（ANDAs）的现代化审评。本研究的目的是评估 GDUFA I 在减少 ANDAs 批准时间和审查周期数量方面的成功，研究时间为 GDUFA I 的五个财政年度。本研究的结果强调了 FDA 在其仿制药项目中的持续进展，并突出了 FDA 与仿制药申请人之间持续的协作沟通过程，这对于及时批准高质量、安全有效的美国公众用仿制药是必要的。
