3/23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。
l3/24付Updated「COVID-19 Vaccines」
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
l3/24付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas#individual-molecular
l3/24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#imported
l3/24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
l3/24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
l3/24付Updated「FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-euas-non-niosh-approved-respirators-during-covid-19-pandemic
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
l3/24付Updated「COVID-19 Vaccines」
https://www.fda.gov/emergency-
l3/24付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l3/24付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
l3/24付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l3/24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-
l3/24付Updated「FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic」
https://www.fda.gov/medical-
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