米国FDA/COVID-19絡みのガイダンス等の発出と更新(2021年3月22日付)
3/22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。
l3/22付Report「Hospitals can use the product report to help determine which outsourcing facilities are compounding drugs used for hospitalized patients with COVID-19」
https://www.fda.gov/media/146726/download
l3/22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
l3/22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
l3/22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
l3/22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
[関連ニュース記事]
l3/22付BioPharmaReporter.com「US trial data shows Oxford-AstraZeneca vaccine is ‘safe and highly effective’」
https://www.biopharma-reporter.com/Article/2021/03/22/US-trial-data-shows-Oxford-AstraZeneca-vaccine-is-safe-and-highly-effective
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
l3/22付Report「Hospitals can use the product report to help determine which outsourcing facilities are compounding drugs used for hospitalized patients with COVID-19」
https://www.fda.gov/media/
l3/22付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l3/22付Updated「Ventilators and Ventilator Accessories EUAs」
https://www.fda.gov/medical-
l3/22付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l3/22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-
[関連ニュース記事]
l3/22付BioPharmaReporter.com「US trial data shows Oxford-AstraZeneca vaccine is ‘safe and highly effective’」
https://www.biopharma-
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