Unwavering Regulatory Safeguards for COVID-19 Vaccines

被引：41

作者：

Shah, Anand ^{[1
]}

Marks, Peter W. ^{[1
]}

Hahn, Stephen M. ^{[1
]}

机构：

[1] US FDA, Silver Spring, MD USA

来源：

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2020年 / 324卷 / 10期

关键词：

D O I：

10.1001/jama.2020.15725

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

This Viewpoint from the FDA reviews the minimum safety and efficacy standards COVID-19 vaccine candidates would need to meet to be considered for approval, and affirms its commitments to evaluating both in diverse populations and to postmarketing surveillance as means to ensure that approval will meet the highest safety and regulatory standards based on science and evidence, not politics.

引用

页码：931 / 932

页数：2

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