Woo Jason, Luan Jingyu Julia, Li Zili, Grosser Stella, Peters John, Chazin Howard
1 US Food and Drug Administration, Office of Generic Drugs, Silver Spring, MD, USA.
2 US Food and Drug Administration, Office of Biostatistics, Silver Spring, MD, USA.
Ther Innov Regul Sci. 2019 Sep;53(5):696-700. doi: 10.1177/2168479018806192. Epub 2018 Oct 25.
Implementation of the first Generic Drug User Fee Amendments of 2012 (GDUFA I) provided funding to the US Food and Drug Administration (FDA) for modernizing review of the FDA/CDER Generic Drug Program. Under GDUFA I, FDA agreed to reduce the backlog of pending generic Abbreviated New Drug Applications (ANDAs), improve the efficiency of generic drug review, and reduce the number of review cycles with the goal of reducing overall time to approval. This study presents a preliminary analysis of initial filing and regulatory first actions on ANDAs during GDUFA I cohort year 3 (CY3) and cohort year 4 (CY4). It highlights initial successes and areas of improvement in the ANDA review process for both FDA and ANDA applicants to improve the efficiency of providing the public with high-quality, affordable generic drugs.
2012年首个仿制药用户收费修正案（GDUFA I）的实施为美国食品药品监督管理局（FDA）提供了资金，用于使FDA/药品评价与研究中心（CDER）仿制药计划的审评现代化。根据GDUFA I，FDA同意减少积压的仿制药简略新药申请（ANDA），提高仿制药审评效率，并减少审评周期数量，目标是缩短总体批准时间。本研究对GDUFA I队列第3年（CY3）和队列第4年（CY4）期间ANDA的首次提交和监管首次行动进行了初步分析。它突出了FDA和ANDA申请人在ANDA审评过程中的初步成功和改进领域，以提高向公众提供高质量、可负担仿制药的效率。
