12/8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。
l12/8付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l12/8付Updated「Coronavirus (COVID-19) Update: December 8, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-december-8-2020
l12/8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
l12/8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
l12/8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
l12/8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
［全体に関するニュース記事］
l12/8付RAPS「VRBPAC to hear of high – and early – efficacy for Pfizer’s COVID vaccine」
https://www.raps.org/news-and-articles/news-articles/2020/12/vrbpac-to-hear-of-high-and-early-efficacy-for-pfiz
l12/8付Outsourcing-Pharma.com「CPhI report looks ahead to post-COVID pharma world 」
https://www.outsourcing-pharma.com/Article/2020/12/08/CPhI-report-looks-ahead-to-post-COVID-pharma-world
l12/8付BioPharmaReporter.com「FDA: No issues around safety and efficacy of Pfizer/BioNTech vaccine candidate 」
https://www.biopharma-reporter.com/Article/2020/12/04/FDA-No-issues-around-safety-and-efficacy-of-Pfizer-BioNTech-vaccine-candidate
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
l12/8付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l12/8付Updated「Coronavirus (COVID-19) Update: December 8, 2020」
https://www.fda.gov/news-
l12/8付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l12/8付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l12/8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-
l12/8付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
［全体に関するニュース記事］
l12/8付RAPS「VRBPAC to hear of high – and early – efficacy for Pfizer’s COVID vaccine」
https://www.raps.org/news-and-
l12/8付Outsourcing-Pharma.com「CP
https://www.outsourcing-
l12/8付BioPharmaReporter.com「FDA
https://www.biopharma-
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