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An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application
被引：0
作者：
Philip T. Lance
Ruth V. Greenaway
Brian Edwards
机构：
[1] The Chartered Institute of Ergonomics and Human Factors (CIEHF),Pharmaceutical Special Interest Group’s Human Factors Studies Subgroup
[2] Cambridge Technology Centre,PA Consulting Group
来源：
Therapeutic Innovation & Regulatory Science
|
2019年
/
53卷
关键词：
human factors;
comparative analysis;
ANDA;
risk analysis;
combination product;
FDA guidance;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
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页码：254 / 263
页数：9
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