3/5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。
l3/5付News Release「Coronavirus (COVID-19) Update: March 5, 2021」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-march-5-2021
l3/5付News Release「Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-adaptive-biotechnologies-t-detect-covid-test
l3/5付News Release「COVID-19 Update: FDA Authorizes Another Tool to Identify if a Person Had a Previous COVID-19 Infection」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-adaptive-biotechnologies-t-detect-covid-test
l3/5付News Release「Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-authorization-first-molecular-non-prescription-home-test
l3/5付 FDA Voices 「Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19」
https://www.fda.gov/news-events/fda-voices/elastomeric-respirator-innovations-play-critical-role-response-covid-19
l3/5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-molecular
l3/5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
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
l3/5付News Release「Coronavirus (COVID-19) Update: March 5, 2021」
https://www.fda.gov/news-
l3/5付News Release「Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test」
https://www.fda.gov/news-
l3/5付News Release「COVID-19 Update: FDA Authorizes Another Tool to Identify if a Person Had a Previous COVID-19 Infection」
https://www.fda.gov/news-
l3/5付News Release「Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test」
https://www.fda.gov/news-
l3/5付 FDA Voices 「Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19」
https://www.fda.gov/news-
l3/5付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l3/5付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
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