米国FDA/COVID-19絡みのガイダンス等の発出と更新(2020年8月14日付)
8/14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。
l8/14付Updated「Coronavirus (COVID-19) Update: Daily Roundup August 14, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-14-2020
l8/14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
l8/14付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixasurgicalmasks
l8/14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
l8/14付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-viral-transport-media-during-covid-19
l8/14付New「Medical Device Shortages During the COVID-19 Public Health Emergency」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency
[上記関連ニュース記事]
l8/14付RAPS「FDA lists medical devices in shortage under CARES authority」
https://www.raps.org/news-and-articles/news-articles/2020/8/fda-lists-medical-devices-in-shortage-under-cares
l8/14付Updated「FDA updates on hand sanitizers consumers should not use」
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
[米国FDAについての全体に関してのニュース記事]
l8/14付RAPS「Unauthorized home COVID test kits targeted by FDA」~未承認の家庭用COVIDテストキット販売業者へのWarning Lettersです。
https://www.raps.org/news-and-articles/news-articles/2020/8/unauthorized-home-covid-test-kits-targeted-by-fda
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。
l8/14付Updated「Coronavirus (COVID-19) Update: Daily Roundup August 14, 2020」
https://www.fda.gov/news-
l8/14付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l8/14付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
l8/14付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l8/14付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
l8/14付New「Medical Device Shortages During the COVID-19 Public Health Emergency」
https://www.fda.gov/medical-
[上記関連ニュース記事]
l8/14付RAPS「FDA lists medical devices in shortage under CARES authority」
https://www.raps.org/news-and-
l8/14付Updated「FDA updates on hand sanitizers consumers should not use」
https://www.fda.gov/drugs/
[米国FDAについての全体に関してのニュース記事]
l8/14付RAPS「Unauthorized home COVID test kits targeted by FDA」~未承認の家庭用COVIDテストキット販売業者へのW
https://www.raps.org/news-and-
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