6/4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。
l6/4付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l6/4付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 4, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-4-2020
l6/4付News Releaase「Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data-kits-part-validation
l6/4付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l6/4付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2
l6/4付Updated「EUA Authorized Serology Test Performance」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance
l6/4付FDA Voices「Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency」～食品関係です。
https://www.fda.gov/media/136142/download
［米国FDAについての全体に関してのニュース記事］
l6/4付Outsourcing-Pharma.com「Newest FDA actions and alerts on COVID-19 」
https://www.outsourcing-pharma.com/Article/2020/06/04/FDA-COVID-19-actions-and-updates
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。
l6/4付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l6/4付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 4, 2020」
https://www.fda.gov/news-
l6/4付News Releaase「Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study」
https://www.fda.gov/news-
l6/4付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l6/4付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l6/4付Updated「EUA Authorized Serology Test Performance」
https://www.fda.gov/medical-
l6/4付FDA Voices「Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency」～食品関係です。
https://www.fda.gov/media/
［米国FDAについての全体に関してのニュース記事］
l6/4付Outsourcing-Pharma.com「New
https://www.outsourcing-
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