3/16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の更新通知等をご参照ください。
l3/16付News Release「Coronavirus (COVID-19) Update: March 16, 2021」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-march-16-2021
l3/16付FDA STATEMENT「Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-steps-streamline-path-covid-19-screening-tools-provides
l3/16付Updated「Ventilators and Ventilator Accessories EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ventilators-and-ventilator-accessories-euas#accessories
l3/15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
l3/16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
l3/15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
l3/16付New「Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/screening-covid-19-deciding-which-test-use-when-establishing-testing-programs
［上記関連ニュース記事］
l3/16付RAPS「FDA smooths the path for COVID screening tests」
https://www.raps.org/news-and-articles/news-articles/2021/3/fda-smooths-the-path-for-covid-screening-tests
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
l3/16付News Release「Coronavirus (COVID-19) Update: March 16, 2021」
https://www.fda.gov/news-
l3/16付FDA STATEMENT「Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs」
https://www.fda.gov/news-
l3/16付Updated「Ventilators and Ventilator Accessories EUAs」
https://www.fda.gov/medical-
l3/15付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l3/16付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l3/15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-
l3/16付New「Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs」
https://www.fda.gov/medical-
［上記関連ニュース記事］
l3/16付RAPS「FDA smooths the path for COVID screening tests」
https://www.raps.org/news-and-
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