3/17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。
l3/17付News Release「FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process」
https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-sars-cov-2-diagnostic-test-using-traditional-premarket-review-process
［上記関連ニュース記事］
l3/17付RAPS「FDA authorizes first COVID test via traditional review pathway」
https://www.raps.org/news-and-articles/news-articles/2021/3/fda-authorizes-first-covid-test-via-traditional-re
l3/17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
l3/17付Updated「Historical Information about Device Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations
l3/17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
l3/17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
l3/17付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-viral-transport-media-during-covid-19
［米国FDAに関するニュース記事］
l3/17付RAPS「Updated: 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
l3/17付Outsourcing-Pharma.com「FDA current COVID-19 updates, actions and advice 」
https://www.outsourcing-pharma.com/Article/2021/03/17/FDA-current-COVID-19-updates-actions-and-advice
［グローバルに関するニュース記事］
l3/17付RAPS「Recon: EU threatens to curb COVID vaccine exports; Pfizer to halt biosimilar manufacturing in China」
https://www.raps.org/news-and-articles/news-articles/2021/3/recon-eu-threatens-to-curb-covid-vaccine-exports-p
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
l3/17付News Release「FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process」
https://www.fda.gov/news-
［上記関連ニュース記事］
l3/17付RAPS「FDA authorizes first COVID test via traditional review pathway」
https://www.raps.org/news-and-
l3/17付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l3/17付Updated「Historical Information about Device Emergency Use Authorizations」
https://www.fda.gov/medical-
l3/17付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l3/17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-
l3/17付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
［米国FDAに関するニュース記事］
l3/17付RAPS「Updated: FDA smooths the path for COVID screening tests」
https://www.raps.org/news-and-
l3/17付Outsourcing-Pharma.com「FD
https://www.outsourcing-
［グローバルに関するニュース記事］
l3/17付RAPS「Recon: EU threatens to curb COVID vaccine exports; Pfizer to halt biosimilar manufacturing in China」
https://www.raps.org/news-and-
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