1997 - 2006年FDA药品批准间隔:信息技术实施期间的分析与比较。

Q4 Medicine

International Journal of Electronic Healthcare Pub Date : 2009-01-01 DOI:10.1504/IJEH.2009.029223

John F Kros, Christopher M Keller

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引用次数: 0

摘要

新信息技术(IT)的实施一直是改善FDA审查间隔的一个持久目标。本文主要研究了三类新药:新药申请(NDA)、补充新药申请(SNDA)和简略新药申请(ANDA)。本文发现ANDA的中位审评时间明显长于NDA和SDNA。应用类中位数的比较显示了显著的差异。尽管最近FDA关注与审查间隔有关的IT实现，但该关注尚未在审查时间上产生统计上的显着改进。

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FDA drug approval intervals from 1997 to 2006: analysis and comparison during information technology implementation.

The implementation of new Information Technology (IT) has been a persistent target for improving FDA review intervals. Three main categories of new drugs are studied: New Drug Application (NDA), the Supplemental New Drug Application (SNDA) and the Abbreviated New Drug Application (ANDA). This paper finds that the median review time for an ANDA was significantly longer than that of an NDA and SDNA. A comparison of application class medians revealed significant differences. Regardless of the recent focus on IT implementations at the FDA pertaining to review intervals, that focus has not yet yielded a statistically significant improvement in review times.

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来源期刊

International Journal of Electronic Healthcare Medicine-Health Policy

CiteScore

1.00

自引率

0.00%

发文量

期刊介绍： The IJEH is an authoritative, fully-refereed international journal which presents current practice and research in the area of e-healthcare. It is dedicated to design, development, management, implementation, technology, and application issues in e-healthcare.