3/23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。
l3/23付News Release「Coronavirus (COVID-19) Update: March 23, 2021」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-march-23-2021
l3/23付New「Center for Drug Evaluation and Research Response to Coronavirus (COVID-19) | Infographic」
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/center-drug-evaluation-and-research-response-coronavirus-covid-19-infographic
l3/23付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas#individual-molecular
l3/23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
l3/23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
l3/23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
［FDA全体に関するニュース記事］
l3/23付BioPharmaReporter.com「NIAID questions potential ‘outdated information’ in AstraZeneca COVID-19 vaccine trial data」～The US National Institute of Allergy and Infectious Diseases (NIAID)がAZ社製ワクチンの初期臨床試験データに疑義を抱いているというものです。
https://www.biopharma-reporter.com/Article/2021/03/23/NIAID-questions-outdated-information-from-AstraZeneca-COVID-19-vaccine-trial
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
l3/23付News Release「Coronavirus (COVID-19) Update: March 23, 2021」
https://www.fda.gov/news-
l3/23付New「Center for Drug Evaluation and Research Response to Coronavirus (COVID-19) | Infographic」
https://www.fda.gov/drugs/
l3/23付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l3/23付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l3/23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-
l3/23付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
［FDA全体に関するニュース記事］
l3/23付BioPharmaReporter.com「NIA
https://www.biopharma-
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