7/29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。
l7/29付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l7/29付Updated「Coronavirus (COVID-19) Update: Daily Roundup July 29, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-july-29-2020
l7/29付News release「Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-posts-new-template-home-and-over-counter-diagnostic-tests-use-non
［上記関連ニュース記事］
l7/29付RAPS「FDA issues at-home and OTC COVID-19 testing template」
https://www.raps.org/news-and-articles/news-articles/2020/7/fda-issues-at-home-and-otc-covid-testing-template
l7/29付New「Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use」
https://www.fda.gov/media/140615/download
l7/29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
l7/29付Updared「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixa
l7/29付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2
l7/29付Updated「Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/antibody-serology-testing-covid-19-information-patients-and-consumers
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。
l7/29付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l7/29付Updated「Coronavirus (COVID-19) Update: Daily Roundup July 29, 2020」
https://www.fda.gov/news-
l7/29付News release「Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools」
https://www.fda.gov/news-
［上記関連ニュース記事］
l7/29付RAPS「FDA issues at-home and OTC COVID-19 testing template」
https://www.raps.org/news-and-
l7/29付New「Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use」
https://www.fda.gov/media/
l7/29付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l7/29付Updared「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
l7/29付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l7/29付Updated「Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers」
https://www.fda.gov/medical-
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