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FDA Oversight of Postmarketing Studies
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2017-09-20 , DOI: 10.1056/nejmc1709185 Mwango Kashoki , Cathryn Lee , Peter Stein
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2017-09-20 , DOI: 10.1056/nejmc1709185 Mwango Kashoki , Cathryn Lee , Peter Stein
The FDA aims to ensure the timely dissemination of information from postmarketing studies of drugs. The authors argue that an analysis of the effect of the FDA Amendments Act would evaluate the timeliness of FDAAA postmarketing requirements separately from that of other types of requirements.
中文翻译:
FDA对上市后研究的监督
FDA旨在确保及时发布药品上市后研究中的信息。作者认为,对《 FDA修正案》效果的分析将评估FDAAA上市后要求的及时性与其他类型要求的及时性。
更新日期:2017-09-20
中文翻译:
FDA对上市后研究的监督
FDA旨在确保及时发布药品上市后研究中的信息。作者认为,对《 FDA修正案》效果的分析将评估FDAAA上市后要求的及时性与其他类型要求的及时性。