2/5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の更新通知等をご参照ください。
l2/4付Updated「COVID-19 Vaccines」
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
l2/5付News Release「Coronavirus (COVID-19) Update: February 5, 2021」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-february-5-2021
l2/4付FDA In Brief「FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data」
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-updates-emergency-use-authorization-covid-19-convalescent-plasma-reflect-new-data
［上記関連ニュース記事］
l2/5付RAPS「FDA narrows convalescent plasma EUA」
https://www.raps.org/news-and-articles/news-articles/2021/2/fda-narrows-convalescent-plasma-eua
l2/5付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-antigen
l2/5付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#exhibit1
l2/5付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-and-emergency-use-authorizations-faqs-testing-sars-cov-2
l2/5付Updated 「Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2
関係者および興味のある方は、下記URLsの更新通知等をご参照
l2/4付Updated「COVID-19 Vaccines」
https://www.fda.gov/emergency-
l2/5付News Release「Coronavirus (COVID-19) Update: February 5, 2021」
https://www.fda.gov/news-
l2/4付FDA In Brief「FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data」
https://www.fda.gov/news-
［上記関連ニュース記事］
l2/5付RAPS「FDA narrows convalescent plasma EUA」
https://www.raps.org/news-and-
l2/5付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l2/5付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
l2/5付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l2/5付Updated 「Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
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