Supporting a data-driven approach to regulatory intelligence

被引：2

作者：

Robertson, Andrew S. ^{[1
]}

Miller, Alexis Reisin ^{[1
]}

Dolz, Felipe ^{[1
]}

机构：

[1] Sanofi, Cambridge, MA 02142 USA

来源：

NATURE REVIEWS DRUG DISCOVERY | 2021年 / 20卷 / 03期

关键词：

DRUG DEVELOPMENT;

D O I：

10.1038/d41573-020-00101-4

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Drug developers are increasingly applying data-driven analysis of the actions of regulatory agencies to gain insights into their expectations and applications of regulatory policy, but such strategies can be limited by the availability and quality of regulatory datasets. Here, we discuss how establishing a single, robust, accessible database of FDA regulatory actions could help address this limitation.

引用

页码：161 / 162

页数：2

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