6/15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。
l6/15付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l6/15付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 15, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-15-2020
l6/15付News Release「Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-warns-newly-discovered-potential-drug-interaction-may-reduce
［上記関連ニュース記事］
l6/15付RAPS「FDA warns of potential drug interaction with remdesivir」
https://www.raps.org/news-and-articles/news-articles/2020/6/fda-warns-of-potential-drug-interaction-with-remde
l6/15付News Release「Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and
［上記関連ニュース記事］
l6/15付RAPS「FDA revokes EUA for hydroxychloroquine, chloroquine」
https://www.raps.org/news-and-articles/news-articles/2020/6/fda-revokes-eua-for-hydroxychloroquine-chloroquine
l6/15付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l6/15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
l6/15付New「Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua-or-discussed-covid-19
また、米国FDAによるWarning Letterですが、こんなニュース記事があります。
l6/15付RAPS「No COVID claims for exosome product, warns FDA」
https://www.raps.org/news-and-articles/news-articles/2020/6/no-covid-claims-for-exosome-product-warns-fda
なお、米国に限らず、COVID-19絡みの違法販売が後を絶たず出ておりますので、ご注意ください。
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。
l6/15付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l6/15付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 15, 2020」
https://www.fda.gov/news-
l6/15付News Release「Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use」
https://www.fda.gov/news-
［上記関連ニュース記事］
l6/15付RAPS「FDA warns of potential drug interaction with remdesivir」
https://www.raps.org/news-and-
l6/15付News Release「Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine」
https://www.fda.gov/news-
［上記関連ニュース記事］
l6/15付RAPS「FDA revokes EUA for hydroxychloroquine, chloroquine」
https://www.raps.org/news-and-
l6/15付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l6/15付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l6/15付New「Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents」
https://www.fda.gov/medical-
また、米国FDAによるWarning Letterですが、こんなニュース記事があります。
l6/15付RAPS「No COVID claims for exosome product, warns FDA」
https://www.raps.org/news-and-
なお、米国に限らず、COVID-19絡みの違法販売が後を絶た
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