米国FDA/COVID-19絡みのガイダンス等の発出と更新(2020年7月10日付)
7/10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。
l7/10付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l7/10付Updated「Coronavirus (COVID-19) Update: Daily Roundup July 10, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-july-10-2020
l7/10付News Release「Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment-system
l7/10付Notice「Study of antibody response to SARS-CoV-2 spike proteins could help inform vaccine design」
https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/study-antibody-response-sars-cov-2-spike-proteins-could-help-inform-vaccine-design
l7/10付Updated「Respiratory Assist Devices EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/respiratory-assist-devices-euas
l7/10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
l7/9付Q&A「Home-Use Blood Glucose Meters Used in Hospitals and Long-Term Care Facilities During the COVID-19 Pandemic」
https://www.fda.gov/medical-devices/blood-glucose-monitoring-devices/home-use-blood-glucose-meters-used-hospitals-and-long-term-care-facilities-during-covid-19-pandemic
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。
l7/10付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l7/10付Updated「Coronavirus (COVID-19) Update: Daily Roundup July 10, 2020」
https://www.fda.gov/news-
l7/10付News Release「Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system」
https://www.fda.gov/news-
l7/10付Notice「Study of antibody response to SARS-CoV-2 spike proteins could help inform vaccine design」
https://www.fda.gov/vaccines-
l7/10付Updated「Respiratory Assist Devices EUAs」
https://www.fda.gov/medical-
l7/10付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l7/9付Q&A「Home-Use Blood Glucose Meters Used in Hospitals and Long-Term Care Facilities During the COVID-19 Pandemic」
https://www.fda.gov/medical-
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