米国FDA/COVID-19絡みのガイダンス等の発出と更新(2020年6月10日付)
※追記更新(2020.06.12)
6/10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。
l6/10付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l6/10付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 10, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-10-2020
l6/10付News Release「Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-next-generation-sequence-test-diagnosing-covid-19
[6/12付追記更新:上記関連ニュース記事]
l6/11付RAPS「FDA grants first EUA for COVID next-generation sequencing」
https://www.raps.org/news-and-articles/news-articles/2020/6/fda-grants-first-eua-for-covid-next-generation-seq
l6/10付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l6/10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
l6/10付New「Hospital Beds, Stretchers, and Mattresses During the COVID-19 Public Health Emergency」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/hospital-beds-stretchers-and-mattresses-during-covid-19-public-health-emergency
[米国FDAについての全体に関してのニュース記事]
l6/10付RAPS「FDA’s CURE ID app gets a COVID-19 refresh」
https://www.raps.org/news-and-articles/news-articles/2020/6/fdas-cureid-app-gets-a-covid-19-refresh-with-drug
l6/10付RAPS「Marks dishes on COVID-19 vaccine development at BIO」~CBER部長Peter Marks氏のワクチン開発の談話です。
https://www.raps.org/news-and-articles/news-articles/2020/6/marks-dishes-on-covid-19-vaccine-development-at-bi
l6/10付Outsourcing-Pharma.com「Current FDA COVID-19 updates and actions 」
https://www.outsourcing-pharma.com/Article/2020/06/10/Current-FDA-COVID-19-updates-and-actions
6/10付の米国FDAによるCOVID-19絡みガイダンス等
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。
l6/10付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l6/10付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 10, 2020」
https://www.fda.gov/news-
l6/10付News Release「Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19」
https://www.fda.gov/news-
[6/12付追記更新:上記関連ニュース記事]
l6/11付RAPS「FDA grants first EUA for COVID next-generation sequencing」
https://www.raps.org/news-and-
l6/10付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l6/10付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l6/10付New「Hospital Beds, Stretchers, and Mattresses During the COVID-19 Public Health Emergency」
https://www.fda.gov/medical-
[米国FDAについての全体に関してのニュース記事]
l6/10付RAPS「FDA’s CURE ID app gets a COVID-19 refresh」
https://www.raps.org/news-and-
l6/10付RAPS「Marks dishes on COVID-19 vaccine development at BIO」~CBER部長Peter Marks氏のワクチン開発の談話です。
https://www.raps.org/news-and-
l6/10付Outsourcing-Pharma.com「Cu
https://www.outsourcing-
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