米国FDA/COVID-19絡みのガイダンス等の発出と更新(2020年9月24日付)
9/24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。
l9/24付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l9/24付Updated「Coronavirus (COVID-19) Update: Daily Roundup September 24, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-september-24-2020
l9/23付News Release「Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-point-care-antibody-test-covid-19
l9/24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
l9/24付Updated「Ventilators and Ventilator Accessories EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ventilators-and-ventilator-accessories-euas#ventilators
l9/24付「Presentation and Transcript added to Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic Webinar - September 15, 2020」
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-series-respirators-and-other-personal-protective-equipment-ppe-health-care-personnel-use#previous
l9/24付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2
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。
l9/24付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l9/24付Updated「Coronavirus (COVID-19) Update: Daily Roundup September 24, 2020」
https://www.fda.gov/news-
l9/23付News Release「Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19」
https://www.fda.gov/news-
l9/24付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l9/24付Updated「Ventilators and Ventilator Accessories EUAs」
https://www.fda.gov/medical-
l9/24付「Presentation and Transcript added to Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic Webinar - September 15, 2020」
https://www.fda.gov/medical-
l9/24付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
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