11/30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。
l11/30付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l11/30付News Release「Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate」～モデルナ社ワクチンEUA申請の話です。
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-second-covid-19-vaccine
［上記関連ニュース記事］
l11/30付RAPS「Moderna files COVID vaccine EUA; adcomm set for 17 December」
https://www.raps.org/news-and-articles/news-articles/2020/11/moderna-filing-with-fda-ema-for-emergency-vaccine
l11/30付BioPharmaReporter.com「Moderna submits EUA request for COVID-19 vaccine: "We believe our vaccine will provide a new and powerful tool that may change the course of this pandemic" 」
https://www.biopharma-reporter.com/Article/2020/11/30/Moderna-submits-request-for-EUA-for-COVID-19-vaccine
l11/30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
l11/30付Updated「Other Medical Device EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/other-medical-device-euas
l11/30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
l11/30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
l11/30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
［全体に関するニュース記事］
l11/30付Outsourcing-Pharma.com「NIAID kicks off fourth iteration of COVID-19 trial 」
https://www.outsourcing-pharma.com/Article/2020/11/30/NIAID-kicks-off-fourth-iteration-of-COVID-19-trial
l11/30付Outsourcing-Pharma.com「COVID-19 fueling decentralized trial surge: Oracle survey 」
https://www.outsourcing-pharma.com/Article/2020/11/30/COVID-19-fueling-decentralized-trial-surge-Oracle-survey
l11/30付BioPharmaReporter.com「Could Pfizer's COVID-19 vaccine get the green light in the UK this week? 」
https://www.biopharma-reporter.com/Article/2020/11/30/Could-Pfizer-COVID-19-vaccine-get-green-light-this-week
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
l11/30付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l11/30付News Release「Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate」～モデルナ社ワクチンEUA申請の話です。
https://www.fda.gov/news-
［上記関連ニュース記事］
l11/30付RAPS「Moderna files COVID vaccine EUA; adcomm set for 17 December」
https://www.raps.org/news-and-
l11/30付BioPharmaReporter.com「Mo
https://www.biopharma-
l11/30付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l11/30付Updated「Other Medical Device EUAs」
https://www.fda.gov/medical-
l11/30付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l11/30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-
l11/30付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
［全体に関するニュース記事］
l11/30付Outsourcing-Pharma.com「N
https://www.outsourcing-
l11/30付Outsourcing-Pharma.com「C
https://www.outsourcing-
l11/30付BioPharmaReporter.com「Co
https://www.biopharma-
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