米国FDA/COVID-19絡みのガイダンス等の発出と更新(2020年11月19日付)

11/19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の更新通知等をご参照ください。
l11/19付News Release「Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19
[全体に関するニュース記事]
l11/19付RAPS「Experts propose changes to FDA’s Accelerated Approval Program」
https://www.raps.org/news-and-articles/news-articles/2020/11/experts-propose-changes-to-fdas-accelerated-approv
l11/19付RAPS「WHO backs off on remdesivir as FDA issues another EUA」
https://www.raps.org/news-and-articles/news-articles/2020/11/who-backs-off-on-remdesivir-as-fda-issues-another
l11/19付RAPS「Pfizer, Moderna COVID vaccines set for imminent EUA filing」
https://www.raps.org/news-and-articles/news-articles/2020/11/pfizer-moderna-covid-vaccines-set-for-imminent-eua
l11/19付BioPharmaReporter.com「A big week for mRNA COVID-19 vaccines: Five key developments」
https://www.biopharma-reporter.com/Article/2020/11/19/A-big-week-for-mRNA-COVID-19-vaccines-Pfizer-Moderna-leap-forward
l11/19付BioPharmaReporter.com「COVID-19 vaccine distribution: Gaps remain in immunization logistics and real-time tracking of vaccine storage and demand 」
https://www.biopharma-reporter.com/Article/2020/11/19/COVID-19-vaccine-distribution-Gaps-remain-in-immunization-logistics-and-real-time-tracking-of-vaccine-storage-and-demand
l11/18付BioPharmaReporter.com「How pharma companies and governments can overcome COVID-19 vaccine hesitancy 」
https://www.biopharma-reporter.com/Article/2020/11/18/How-pharma-companies-and-governments-can-overcome-COVID-19-vaccine-hesitancy
関係者および興味のある方は、下記URLsの更新通知等をご参照
l11/19付News Release「Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19」
https://www.fda.gov/news-
[全体に関するニュース記事]
l11/19付RAPS「Experts propose changes to FDA’s Accelerated Approval Program」
https://www.raps.org/news-and-
l11/19付RAPS「WHO backs off on remdesivir as FDA issues another EUA」
https://www.raps.org/news-and-
l11/19付RAPS「Pfizer, Moderna COVID vaccines set for imminent EUA filing」
https://www.raps.org/news-and-
l11/19付BioPharmaReporter.com「A big week for mRNA COVID-19 vaccines: Five key developments」
https://www.biopharma-
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https://www.biopharma-
l11/18付BioPharmaReporter.com「Ho
https://www.biopharma-
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