4/17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。
この数週間の緊急通知発出を見る限り、米国の医療状況が相当苦しんでいることが窺われます。
本邦が同様の状況に陥らないことを期待しましょう。
関係者および興味のある方は、下記URLsのガイダンス等をご参照ください。
l4/17付Updated「Coronavirus (COVID-19) Update: Daily Roundup April 17, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-17-2020
l4/17付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l4/17付News Release「Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-federal-judge-enters-temporary-injunction-against-genesis-ii-church
l4/17付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l4/17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
l4/17付「Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care ProvidersImportant Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers」
https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers
l4/17付「FDA Fact Sheet - Serological Testing for Antibodies to SARS-CoV-2 Infection」
https://www.fda.gov/media/137111/download
この数週間の緊急通知発出を見る限り、
本邦が同様の状況に陥らないことを期待しましょう。
関係者および興味のある方は、下記URLsのガイダンス等をご参
l4/17付Updated「Coronavirus (COVID-19) Update: Daily Roundup April 17, 2020」
https://www.fda.gov/news-
l4/17付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l4/17付News Release「Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19」
https://www.fda.gov/news-
l4/17付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l4/17付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l4/17付「Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care ProvidersImportant Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers」
https://www.fda.gov/medical-
l4/17付「FDA Fact Sheet - Serological Testing for Antibodies to SARS-CoV-2 Infection」
https://www.fda.gov/media/
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