1/26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。
l1/28付最終ガイダンス「Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)」
https://www.fda.gov/media/145135/download
［米国FDAにおけるCOVID-19関連ニュース記事］
l1/28付RAPS「FDA: Exclusion not necessary for EUA vaccine, therapeutic recipients」
https://www.raps.org/news-and-articles/news-articles/2021/1/fda-exclusion-not-necessary-for-eua-vaccine-therap
l1/28付Outsourcing-Pharma.com「FDA COVID-19 responses and recommendations this week 」
https://www.outsourcing-pharma.com/Article/2021/01/28/FDA-COVID-19-responses-and-recommendations-this-week
l1/27付BioPharmaReporter.com「US: Can the DPA make a dent in the vaccine supply needs of the COVID-19 pandemic?」
https://www.biopharma-reporter.com/Article/2021/01/27/US-Can-the-DPA-make-a-dent-in-the-vaccine-supply-needs-of-the-COVID-19-pandemi
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
l1/28付最終ガイダンス「Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)」
https://www.fda.gov/media/
［米国FDAにおけるCOVID-19関連ニュース記事］
l1/28付RAPS「FDA: Exclusion not necessary for EUA vaccine, therapeutic recipients」
https://www.raps.org/news-and-
l1/28付Outsourcing-Pharma.com「FD
https://www.outsourcing-
l1/27付BioPharmaReporter.com「US: Can the DPA make a dent in the vaccine supply needs of the COVID-19 pandemic?」
https://www.biopharma-
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