米国FDA/COVID-19絡みのガイダンス等の発出と更新(2020年6月2日付)
※追記更新(2020.06.04)
6/2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。
l6/2付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l6/2付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-2-2020
l6/1付Updated「Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-protect-public-health-increase-supply-alcohol-based
l6/2付ガイダンス「Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency」
https://www.fda.gov/media/138496/download
[6/3付追記更新:上記関連ニュース記事]
l6/3付RAPS「FDA eases IRB review of COVID-19 expanded access requests」
https://www.raps.org/news-and-articles/news-articles/2020/6/fda-eases-irb-review-of-covid-19-expanded-access-r
l6/2付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l6/2付FDA Voices「Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety」~食品関係です。
https://www.fda.gov/news-events/fda-voices/pandemic-challenges-highlight-importance-new-era-smarter-food-safety
6/2付の米国FDAによるCOVID-19絡みガイダンス等の
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。
l6/2付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l6/2付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020」
https://www.fda.gov/news-
l6/1付Updated「Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer」
https://www.fda.gov/news-
l6/2付ガイダンス「Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency」
https://www.fda.gov/media/
[6/3付追記更新:上記関連ニュース記事]
l6/3付RAPS「FDA eases IRB review of COVID-19 expanded access requests」
https://www.raps.org/news-and-
l6/2付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l6/2付FDA Voices「Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety」~食品関係です。
https://www.fda.gov/news-
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