6/17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。
l6/17付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l6/16付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 17, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-17-2020
l6/16付ガイダンス「Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency」
https://www.fda.gov/media/139145/download
［上記関連ニュース記事］
l6/17付RAPS「FDA offers statistical guidance for trials impacted by COVID-19」
https://www.raps.org/news-and-articles/news-articles/2020/6/fda-offers-statistical-guidance-for-trials-impacte
l6/17付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l6/17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
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。
l6/17付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l6/16付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 17, 2020」
https://www.fda.gov/news-
l6/16付ガイダンス「Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency」
https://www.fda.gov/media/
［上記関連ニュース記事］
l6/17付RAPS「FDA offers statistical guidance for trials impacted by COVID-19」
https://www.raps.org/news-and-
l6/17付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l6/17付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
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