※追記更新（2020.05.13）
※追記更新（2020.05.16）
5/11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。
この数週間の緊急通知発出を見る限り、米国の医療状況が相当苦しんでいることが窺われます。
本邦が同様の状況に陥らないことを期待しましょう。
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。
l5/11付News Release「Coronavirus (COVID-19) Update: Daily Roundup May 11, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-11-2020
l5/11付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l5/11付News Release「Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-surveillance-inspections-during-covid-19
［5/13付追記更新：上記関連ニュース記事］
l5/12付RAPS「FDA plans phased approach to restarting surveillance inspections」
https://www.raps.org/news-and-articles/news-articles/2020/5/fda-plans-phased-approach-to-restarting-surveillan
［5/16付追記更新：上記関連ニュース記事］
l5/15付GMP Verlag「US FDA: Gradual restart of surveillance inspections」
https://www.gmp-publishing.com/content/en/gmp-news/news-about-gmp-cgmp/d/us-fda-gradual-restart-of-surveillance-inspections
l5/11付News Release「Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-new-actions-accelerate-development-novel-prevention-treatment
［5/13付追記更新：上記関連ニュース記事］
l5/12付RAPS「FDA issues two guidances to accelerate COVID-19 treatments」
https://www.raps.org/news-and-articles/news-articles/2020/5/fda-issues-two-guidances-to-accelerate-covid-19-tr
l5/11付ガイダンス「COVID-19: Developing Drugs and Biological Products for Treatment or Prevention」
https://www.fda.gov/media/137926/download
l5/11付ガイダンス「Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic」
https://www.fda.gov/media/72498/download
l5/11付ガイダンス「COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products」
https://www.fda.gov/media/137927/download
l5/11付改訂ガイダンス「Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)」
https://www.fda.gov/media/135659/download
l5/9付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l5/9付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2
l5/11付Notice「Face Masks and Surgical Masks for COVID-19: Manufacturing, Purchasing, Importing, and Donating Masks During the Public Health Emergency」
https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/face-masks-and-surgical-masks-covid-19-manufacturing-purchasing-importing-and-donating-masks-during
※追記更新（2020.05.16）
5/11付の米国FDAによるCOVID-19絡みガイダンス等
この数週間の緊急通知発出を見る限り、
本邦が同様の状況に陥らないことを期待しましょう。
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。
l5/11付News Release「Coronavirus (COVID-19) Update: Daily Roundup May 11, 2020」
https://www.fda.gov/news-
l5/11付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l5/11付News Release「Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19」
https://www.fda.gov/news-
［5/13付追記更新：上記関連ニュース記事］
l5/12付RAPS「FDA plans phased approach to restarting surveillance inspections」
https://www.raps.org/news-and-
［5/16付追記更新：上記関連ニュース記事］
l5/15付GMP Verlag「US FDA: Gradual restart of surveillance inspections」
https://www.gmp-publishing.
l5/11付News Release「Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19」
https://www.fda.gov/news-
［5/13付追記更新：上記関連ニュース記事］
l5/12付RAPS「FDA issues two guidances to accelerate COVID-19 treatments」
https://www.raps.org/news-and-
l5/11付ガイダンス「COVID-19: Developing Drugs and Biological Products for Treatment or Prevention」
https://www.fda.gov/media/
l5/11付ガイダンス「Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic」
https://www.fda.gov/media/
l5/11付ガイダンス「COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products」
https://www.fda.gov/media/
l5/11付改訂ガイダンス「Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)」
https://www.fda.gov/media/
l5/9付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l5/9付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l5/11付Notice「Face Masks and Surgical Masks for COVID-19: Manufacturing, Purchasing, Importing, and Donating Masks During the Public Health Emergency」
https://www.fda.gov/medical-
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