疫情时事：国食品药品监督管理局今天宣布将采取以下行动应对新冠病毒

阿拉丁翻译苏琳

Coronavirus (COVID-19) Update: Daily Roundup April 1, 2020

疫情时事：2020年4月1日疫情概况

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
美国食品药品监督管理局今天宣布将采取以下行动应对新冠病毒：

l FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available: In response to the COVID-19 pandemic, the FDA—in collaboration with the Centers for Disease Control and Prevention (CDC), the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) and the Institute for Genome Sciences at the University of Maryland and the National Center for Biotechnology Information (NCBI)—developed quality-controlled, reference sequence data for the SARS-CoV-2 reference strain for the United States. Availability of traceable and quality-controlled data will help test developers and vaccine developers:

目前，已可在FDA监管级别微生物序列数据库查询SARS-CoV-2参考级别序列数据：为应对新冠病毒，FDA联合疾病控制与预防中心（CDC），生物防御和新兴传染病研究资源库（BEI资源库）、马里兰大学基因组科学研究所和美国国家生物技术信息中心（NCBI），为美国SARS-CoV-2参考菌株开发了质量受控的参考序列数据。可追踪且质量可控的数据可在以下方面对测试研发人员和疫苗研发人员产生帮助：

l Expedite development of medical countermeasures.

l Identify new or more stable targets for future tests.

l Enable in silico confirmation of targets.

l Support development of synthetic reference material.

l Enable viral population/quasi species analysis.

医疗对策的开展。

未来新的或更稳定的测试目标对象的确认。

目标对象的电子确认。

合成标准物质的开发。

病毒种群/准种的分析。

l The FDA issued a Constituent Update regarding guidance it released today to provide temporary flexibility to chain restaurants and similar retail food establishments currently required to provide nutrition information, including calories, on menus and menu boards.

FDA于今日更新了成分指南，旨在为连锁餐厅和类似的零售食品企业提供临时变动指南，目前菜单上需要标明营养成分，包括卡路里等。

l The FDA is continuing to issue warning letters to companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. FDA and FTC issued a warning letter to Neuro XPF, which sells cannabidiol (CBD) products in the U.S. with the misleading claim these products can mitigate, prevent, treat, diagnose, or cure COVID-19. The agency will continue to pursue those that place public health at risk.

为保护消费者权益，FDA将继续向欺诈性销售新冠相关产品的公司发出警告信。FDA和FTC已向Neuro XPF发出了警告信，因为其在美国销售大麻二酚类（CBD）产品，并误导性地宣称这些产品可以缓解、预防、治疗、诊断或治愈新冠。FDA将继续追查对公共健康造成危害的企业和个人。

l Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 23 emergency use authorizations have been issued for diagnostic tests. Under this EUA, FDA has authorized Yale New Haven Hospital’s SARS-CoV-2 PCR test. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

诊断最新进展：在新冠疫情期间，FDA已与220多名测试研发人员展开合作，他们表示将向FDA提交检测病毒的紧急使用授权（EUA）申请。迄今为止，已就诊断测试签发了23项紧急使用授权。根据该项紧急使用授权条例，FDA已经批准了耶鲁纽黑文医院的SARS-CoV-2 PCR检测。此外，FDA还知悉，已有超过110家实验室遵照《突发公共卫生事件指南》，开始按照新冠病毒诊断测试政策中的规定进行测试。FDA将持续更新有关新冠诊断的问答。

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