12/7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。
l12/4付News Release「Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-and-flu-combination-test-use-home
l12/7付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l12/7付Updated「Decontamination Systems for Personal Protective Equipment EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/decontamination-systems-personal-protective-equipment-euas
l12/7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
l12/7付Updated「EUA Authorized Serology Test Performance」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance
l12/7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
［全体に関するニュース記事］
l12/7付Outsourcing-Pharma.com「Ancestry study explores COVID-19 genetic risks 」
https://www.outsourcing-pharma.com/Article/2020/12/07/Ancestry-study-explores-COVID-19-genetic-risks
l12/7付Outsourcing-Pharma.com「How has COVID-19 impacted clinical trial data collection? 」
https://www.outsourcing-pharma.com/Article/2020/12/07/How-has-COVID-19-impacted-clinical-trial-data-collection
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
l12/4付News Release「Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples」
https://www.fda.gov/news-
l12/7付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l12/7付Updated「Decontamination Systems for Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
l12/7付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l12/7付Updated「EUA Authorized Serology Test Performance」
https://www.fda.gov/medical-
l12/7付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
［全体に関するニュース記事］
l12/7付Outsourcing-Pharma.com「An
https://www.outsourcing-
l12/7付Outsourcing-Pharma.com「Ho
https://www.outsourcing-
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