※追記更新（2020.10.27）
10/22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の更新通知等をご参照ください。
l10/22付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l10/22付News Release「FDA Approves First Treatment for COVID-19」
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19
l10/22付「FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness」～WHOはダメ出ししましたが、FDAは認可したようです。
https://www.fda.gov/drugs/drug-safety-and-availability/fdas-approval-veklury-remdesivir-treatment-covid-19-science-safety-and-effectiveness
［上記関連ニュース記事］
l10/22付RAPS「Remdesivir receives FDA approval for COVID-19」
https://www.raps.org/news-and-articles/news-articles/2020/10/remdesivir-receives-fda-approval-for-covid-19
［10/27付追記更新：上記関連ニュース記事］
l10/27付Outsourcing-Pharma.com「FDA okays first COVID-19 treatment 」
https://www.outsourcing-pharma.com/Article/2020/10/26/FDA-okays-first-COVID-19-treatment
l10/22付ADVISORY COMMITTEE MEETING「Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement」
https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-22-2020-meeting-announcement#event-materials
［10/27付追記更新：上記関連ニュース記事］
l10/23付RAPS「FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom」
https://www.raps.org/news-and-articles/news-articles/2020/10/fdas-covid-19-vaccine-adcomm-raises-questions-as-f
l10/22付FDA Voices「The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines」
https://www.fda.gov/news-events/fda-voices/fdas-vaccines-and-related-biological-products-advisory-committee-and-its-role-advising-agency-covid
［上記関連ニュース記事］
l10/22付RAPS「FDA plans master protocols to monitor COVID vaccine safety, efficacy」
https://www.raps.org/news-and-articles/news-articles/2020/10/fda-plans-master-protocols-to-monitor-covid-vaccin
l10/22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
l10/22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
l10/22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
10/22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の更新通知等をご参照
l10/22付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l10/22付News Release「FDA Approves First Treatment for COVID-19」
https://www.fda.gov/news-
l10/22付「FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness」～WHOはダメ出ししましたが、F
https://www.fda.gov/drugs/
［上記関連ニュース記事］
l10/22付RAPS「Remdesivir receives FDA approval for COVID-19」
https://www.raps.org/news-and-
［10/27付追記更新：上記関連ニュース記事］
l10/27付Outsourcing-Pharma.com「F
https://www.outsourcing-
l10/22付ADVISORY COMMITTEE MEETING「Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement」
https://www.fda.gov/advisory-
［10/27付追記更新：上記関連ニュース記事］
l10/23付RAPS「FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom」
https://www.raps.org/news-and-
l10/22付FDA Voices「The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines」
https://www.fda.gov/news-
［上記関連ニュース記事］
l10/22付RAPS「FDA plans master protocols to monitor COVID vaccine safety, efficacy」
https://www.raps.org/news-and-
l10/22付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l10/22付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l10/22付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
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