对 2013-2022 财政年度《非专利药品用户费法》(GDUFA)计划的评估。

IF 5 3区 医学 Q1 PHARMACOLOGY & PHARMACY AAPS Journal Pub Date : 2024-07-24 DOI:10.1208/s12248-024-00948-0
Erica L Friedman, Leah W Falade, Michael G Bartlett
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引用次数: 0

摘要

对《非专利药品使用费法案》(GDUFA)前两次授权中提出的监管举措、战略和激励措施的有效性进行了评估,评估因素包括简略新药申请(ANDA)撤回数量和第一周期批准数量。GDUFA 最初于 2012 年获得 2013-2017 财年授权(GDUFA I),并于 2018-2022 财年再次获得授权(GDUFA II)。从 2013-2022 年的 Drugs @ FDA 数据库中分析了 ANDA 批准情况。从这些申请中,我们注意到了批准时间、剂型和给药途径 (ROA)、产品适应症、产品的市场地位、首仿药地位、申请 ANDA 的公司和公司规模。尽管 COVID 大流行,但与 GDUFA I 相比,GDUFA II 期间的 ANDA 批准量增加了 40%以上。在 GDUFA II 期间,撤回的申请增加了 120%以上,这反映了现在为鼓励公司在审查前撤回不充分的申请而提供的部分退款。这似乎也促成了第一周期批准数量的增加,在 GDUFA I 和 II 期之间增加了 100%。由于 COVID-19 公共卫生突发事件,仿制药计划和市场活动有所减少。因此,在观察本研究的实际趋势时,必须考虑到这一影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013-2022.

The effectiveness of the regulatory initiatives, strategies, and incentives put forth in the first two authorizations of the Generic Drug User Fees Act (GDUFA) were evaluated using factors including the number of Abbreviated New Drug Application (ANDA) withdrawals and first-cycle approvals. GDUFA was originally authorized in 2012 for FY 2013-2017 (GDUFA I) and reauthorized for FY 2018-2022 (GDUFA II). ANDA approvals were analyzed from the Drugs @ FDA database covering 2013-2022. From the applications, the approval time, dosage form and route of administration (ROA), product indication, market status of the product, first generic status, company and company size filing the ANDA were noted. Despite the COVID pandemic, there was more than a 40% increase in ANDA approvals during GDUFA II relative to GDUFA I. Oral and parenteral drugs were the two leading categories of approved generics during both iterations of GDUFA. There was more than a 120% increase in withdrawn applications during GDUFA II, which reflects the partial refund that is now offered to incentivize companies to withdraw inadequate applications prior to review. This also appears to have contributed to an increase in the number of first-cycle approvals, which increased by 100% between GDUFA I and II. Due to the COVID-19 public health emergency, there was a decrease in activity within the generic drug program and market. Therefore, it is important to consider this impact when observing actual trends from this study.

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来源期刊
AAPS Journal
AAPS Journal 医学-药学
CiteScore
7.80
自引率
4.40%
发文量
109
审稿时长
1 months
期刊介绍: The AAPS Journal, an official journal of the American Association of Pharmaceutical Scientists (AAPS), publishes novel and significant findings in the various areas of pharmaceutical sciences impacting human and veterinary therapeutics, including: · Drug Design and Discovery · Pharmaceutical Biotechnology · Biopharmaceutics, Formulation, and Drug Delivery · Metabolism and Transport · Pharmacokinetics, Pharmacodynamics, and Pharmacometrics · Translational Research · Clinical Evaluations and Therapeutic Outcomes · Regulatory Science We invite submissions under the following article types: · Original Research Articles · Reviews and Mini-reviews · White Papers, Commentaries, and Editorials · Meeting Reports · Brief/Technical Reports and Rapid Communications · Regulatory Notes · Tutorials · Protocols in the Pharmaceutical Sciences In addition, The AAPS Journal publishes themes, organized by guest editors, which are focused on particular areas of current interest to our field.
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