米国FDA/COVID-19絡みのガイダンス等の発出と更新(2020年6月16日付)
※追記更新(2020.06.18)
6/16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。
l6/16付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l6/16付News Release「Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chembio-antibody-test
[6/18付追記更新:上記関連ニュース記事]
l6/17付RAPS「FDA yanks EUA for serology test」
https://www.raps.org/news-and-articles/news-articles/2020/6/fda-yanks-eua-for-serology-test
l6/16付News Release「Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-facilitating-diagnostic-test-availability-asymptomatic-testing-and
l6/16付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l6/16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
l6/16付Updated「Historical Information about Device Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/historical-information-about-device-emergency-use-authorizations
6/16付の米国FDAによるCOVID-19絡みガイダンス等
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。
l6/16付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l6/16付News Release「Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test」
https://www.fda.gov/news-
[6/18付追記更新:上記関連ニュース記事]
l6/17付RAPS「FDA yanks EUA for serology test」
https://www.raps.org/news-and-
l6/16付News Release「Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling」
https://www.fda.gov/news-
l6/16付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l6/16付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l6/16付Updated「Historical Information about Device Emergency Use Authorizations」
https://www.fda.gov/medical-
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