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Supporting a data-driven approach to regulatory intelligence.
Nature Reviews Drug Discovery ( IF 122.7 ) Pub Date : 2020-05-28 , DOI: 10.1038/d41573-020-00101-4
Andrew S. Robertson , Alexis Reisin Miller , Felipe Dolz

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.

中文翻译:

支持数据驱动的监管智能方法。

药物开发商越来越多地对监管机构的行为进行数据驱动的分析,以深入了解其对监管政策的期望和应用,但是这种策略可能会受到监管数据集的可用性和质量的限制。在这里,我们讨论建立一个单一,健壮,可访问的FDA监管措施数据库如何帮助解决这一局限性。
更新日期:2020-05-28
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