6/30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News Release等をご参照ください。
l6/30付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l6/30付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 30, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-30-2020
l6/30付News Release「FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-facilitate-timely-development-safe-effective-covid
l6/30付ガイダンス「Development and Licensure of Vaccines to Prevent COVID-19」
https://www.fda.gov/media/139638/download
［上記関連ニュース記事］
l6/30付RAPS「FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold」
https://www.raps.org/news-and-articles/news-articles/2020/6/fda-issues-covid-19-vaccine-guidance-setting-50-ef
l6/30付ガイダンス「Development and Licensure of Vaccines to Prevent COVID-19」
https://www.fda.gov/media/139638/download
l6/30付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l6/30付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2
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。
l6/30付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l6/30付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 30, 2020」
https://www.fda.gov/news-
l6/30付News Release「FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines」
https://www.fda.gov/news-
l6/30付ガイダンス「Development and Licensure of Vaccines to Prevent COVID-19」
https://www.fda.gov/media/
［上記関連ニュース記事］
l6/30付RAPS「FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold」
https://www.raps.org/news-and-
l6/30付ガイダンス「Development and Licensure of Vaccines to Prevent COVID-19」
https://www.fda.gov/media/
l6/30付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l6/30付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
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