※追記更新（2020.11.19）
11/17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。
l11/17付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l11/17付Updated「Coronavirus (COVID-19) Update: November 17, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-november-17-2020
l11/17付Updated「COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs」
https://www.fda.gov/news-events/press-announcements/covid-19-update-fdas-ongoing-commitment-transparency-covid-19-euas
［上記関連ニュース記事］
l11/17付RAPS「FDA commits to data transparency in COVID EUAs」
https://www.raps.org/news-and-articles/news-articles/2020/11/fda-commits-to-data-transparency-in-covid-euas
l11/17付News Release「Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home」～FDAは自宅でのCOVID-19自己検査キットのEUA（緊急使用承認）です。
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home
［11/19付追記更新：上記関連ニュース記事］
l11/18付RAPS「COVID rapid diagnostic options expand with at-home LAMP test」
https://www.raps.org/news-and-articles/news-articles/2020/11/covid-rapid-diagnostic-options-expand-with-at-home
l11/17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
l11/17付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-and-emergency-use-authorizations-faqs-testing-sars-cov-2
l11/17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
l11/17付Updated「Coronavirus Treatment Acceleration Program (CTAP)」
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
［全体に関するニュース記事］
l11/17付RAPS「Hahn addresses EUAs, transition to approvals in conversation with RAPS members」
https://www.raps.org/news-and-articles/news-articles/2020/11/hahn-addresses-euas-transition-to-approvals-in-con
【11/19付追記更新】
l11/18付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-and-emergency-use-authorizations-faqs-testing-sars-cov-2
l11/18付Updated「Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2
l11/18付「FDA COVID-19 news roundup this week」
https://www.outsourcing-pharma.com/Article/2020/11/18/FDA-COVID-19-news-roundup-this-week
11/17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
l11/17付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l11/17付Updated「Coronavirus (COVID-19) Update: November 17, 2020」
https://www.fda.gov/news-
l11/17付Updated「COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs」
https://www.fda.gov/news-
［上記関連ニュース記事］
l11/17付RAPS「FDA commits to data transparency in COVID EUAs」
https://www.raps.org/news-and-
l11/17付News Release「Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home」～FDAは自宅でのCOVID-19自己検査キットの
https://www.fda.gov/news-
［11/19付追記更新：上記関連ニュース記事］
l11/18付RAPS「COVID rapid diagnostic options expand with at-home LAMP test」
https://www.raps.org/news-and-
l11/17付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l11/17付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l11/17付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
l11/17付Updated「Coronavirus Treatment Acceleration Program (CTAP)」
https://www.fda.gov/drugs/
［全体に関するニュース記事］
l11/17付RAPS「Hahn addresses EUAs, transition to approvals in conversation with RAPS members」
https://www.raps.org/news-and-
【11/19付追記更新】
l11/18付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l11/18付Updated「Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l11/18付「FDA COVID-19 news roundup this week」
https://www.outsourcing-
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
コメント
/
/
/
コメント