7/20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News Release等をご参照ください。
l7/20付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l7/20付Updated「Coronavirus (COVID-19) Update: Daily Roundup July 20, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-july-20-2020
l7/20付ガイダンス「Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/140300/download
［上記関連ニュース記事］
l7/20付RAPS「FDA issues enforcement policy for coronavirus transport media」
https://www.raps.org/news-and-articles/news-articles/2020/7/fda-issues-enforcement-policy-for-coronavirus-tran
l7/18付News Release「Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-authorization-sample-pooling-diagnostic
［上記関連ニュース記事］
l7/20付RAPS「FDA approves pooled sampling for COVID-19 test」
https://www.raps.org/news-and-articles/news-articles/2020/7/fda-approves-pooled-sampling-for-covid-19-test
l7/20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
l7/20付Updated「FAQs on Diagnostic Testing for SARS-CoV-2
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2
l7/20付「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
l7/20付FDA Voices「FDA’s Continued Commitment to the Safety and Security of Our Laboratories」
https://www.fda.gov/news-events/fda-voices/fdas-continued-commitment-safety-and-security-our-laboratories
l7/20付FDA Voices「FDA Protects Patients and Consumers from Fraud During COVID-19」
https://www.fda.gov/news-events/fda-voices/fda-protects-patients-and-consumers-fraud-during-covid-19
関係者および興味のある方は、下記URLsのNews Release等をご参照ください。
l7/20付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l7/20付Updated「Coronavirus (COVID-19) Update: Daily Roundup July 20, 2020」
https://www.fda.gov/news-
l7/20付ガイダンス「Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/
［上記関連ニュース記事］
l7/20付RAPS「FDA issues enforcement policy for coronavirus transport media」
https://www.raps.org/news-and-
l7/18付News Release「Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing」
https://www.fda.gov/news-
［上記関連ニュース記事］
l7/20付RAPS「FDA approves pooled sampling for COVID-19 test」
https://www.raps.org/news-and-
l7/20付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l7/20付Updated「FAQs on Diagnostic Testing for SARS-CoV-2
https://www.fda.gov/medical-
l7/20付「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
l7/20付FDA Voices「FDA’s Continued Commitment to the Safety and Security of Our Laboratories」
https://www.fda.gov/news-
l7/20付FDA Voices「FDA Protects Patients and Consumers from Fraud During COVID-19」
https://www.fda.gov/news-
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