FDA Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry
标准简介
Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry[附网盘链接]是Food&Drug Administration于之前发布的FDA标准，适用于美国。标准截图
![Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry[附网盘链接]](/img/20210914103721no8ar.jpg)
标准文档说明
标准文档类型为Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Contains Nonbinding Recommendations Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic which has been caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19. This guidance is intended to remain in effect for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). The recommendations described in the guidance are expected to assist the Agency and sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19 and reflect the Agency’s current thinking on this issue. Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019” (85 FR 16949), available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-
06222.pdf, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 371(h)(1)(C)), and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. However, FDA expects that the recommendations set forth in this revised guidance will continue to apply outside the context of the current public health emergency. 1
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