6/25付の米国FDAによるCOVID-19絡みガイダンス等の発出について、筆者のお好みでお伝えします。
関係者および興味のある方は、下記URLsのNews Release等をご参照ください。
l6/25付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l6/25付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 25, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-25-2020
l6/24付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l6/24付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2
l6/25付「Presentations and Transcripts added to June 10 and June 17 Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests」
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-immediately-effect-guidance-coronavirus-covid-19-diagnostic-tests-07012020#previous
l6/25付「Presentation and Transcript added to June 9 Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic」
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-series-respirators-health-care-personnel-use-during-covid-19-pandemic-06232020-06232020#previous
［EUAに関するニュース記事］
l6/25付RAPS「Revise remdesivir EUA to add registry, say researchers」～緊急使用としてのレムデシビルに関するものです。
https://www.raps.org/news-and-articles/news-articles/2020/6/revise-remdesivir-eua-to-add-registry-say-research
［米国FDAについての全体に関してのニュース記事］
l6/25付Outsourcing-Pharma.com「This week's FDA COVID-19 actions and advice 」
https://www.outsourcing-pharma.com/Article/2020/06/25/FDA-issues-COVID-19-industry-updates
関係者および興味のある方は、下記URLsのNews Release等をご参照ください。
l6/25付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l6/25付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 25, 2020」
https://www.fda.gov/news-
l6/24付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l6/24付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l6/25付「Presentations and Transcripts added to June 10 and June 17 Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests」
https://www.fda.gov/medical-
l6/25付「Presentation and Transcript added to June 9 Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic」
https://www.fda.gov/medical-
［EUAに関するニュース記事］
l6/25付RAPS「Revise remdesivir EUA to add registry, say researchers」～
https://www.raps.org/news-and-
［米国FDAについての全体に関してのニュース記事］
l6/25付Outsourcing-Pharma.com「Th
https://www.outsourcing-
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