※追記更新（2020.10.15）
10/13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。
l10/13付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l10/13付Updated「Coronavirus (COVID-19) Update: Daily Roundup October 13, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-october-13-2020
l最終ガイダンス「Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/142933/download
［10/15付追記更新：上記関連ニュース記事］
l10/14付RAPS「During pandemic, FDA permits some respiratory swab, media swaps」
https://www.raps.org/news-and-articles/news-articles/2020/10/during-pandemic-fda-permits-some-respiratory-swab
l10/13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
l10/13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#exhibit1
l10/13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#VTM
l10/13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#offeringtests
［全体に関するニュース記事］
l10/14付Outsourcing-Pharma.com「Current FDA COVID-19 advice and actions 」
https://www.outsourcing-pharma.com/Article/2020/10/14/Current-FDA-COVID-19-advice-and-actions
10/13付の米国FDAによるCOVID-19絡みガイダンス
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。
l10/13付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l10/13付Updated「Coronavirus (COVID-19) Update: Daily Roundup October 13, 2020」
https://www.fda.gov/news-
l最終ガイダンス「Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/
［10/15付追記更新：上記関連ニュース記事］
l10/14付RAPS「During pandemic, FDA permits some respiratory swab, media swaps」
https://www.raps.org/news-and-
l10/13付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l10/13付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
l10/13付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
l10/13付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
［全体に関するニュース記事］
l10/14付Outsourcing-Pharma.com「C
https://www.outsourcing-
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