米国FDA/COVID-19絡みのガイダンス等の発出と更新(2021年7月16日付)
7/13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の更新通知等をご参照
● 7/16付Updated「Coronavirus (COVID-19) | Drugs」
https://www.fda.gov/drugs/
● 7/16付News Release「Coronavirus (COVID-19) Update: July 16, 2021」
https://www.fda.gov/news-
● 7/16付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
● 7/15付Updated「Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
● 7/15付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
● 7/15付New「Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices - New Product Codes」
https://www.fda.gov/medical-
● 7/15付Updated「Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents」
https://www.fda.gov/medical-
● 7/15付Updated「Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication」
https://www.fda.gov/medical-
● 7/15付Updated「In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2」
https://www.fda.gov/medical-
● 7/15付Updated「In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2」
https://www.fda.gov/medical-
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