1/29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。
l1/29付Updated「COVID-19 Vaccines」
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
l1/29付Updated「Coronavirus (COVID-19) Update: January 29, 2021」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-january-29-2021
l1/29付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-molecular
l1/29付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-and-emergency-use-authorizations-faqs-testing-sars-cov-2
l1/29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-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2
l1/28付FDA「Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic」
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/bioequivalence-studies-submission-andas-during-covid-19-pandemic
l1/29付RAPS「FDA eyes adaptive designs for BE studies impacted by COVID-19」
https://www.raps.org/news-and-articles/news-articles/2021/1/fda-eyes-adaptive-designs-for-be-studies-impacted
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
l1/29付Updated「COVID-19 Vaccines」
https://www.fda.gov/emergency-
l1/29付Updated「Coronavirus (COVID-19) Update: January 29, 2021」
https://www.fda.gov/news-
l1/29付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l1/29付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l1/29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-
l1/28付FDA「Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic」
https://www.fda.gov/drugs/
l1/29付RAPS「FDA eyes adaptive designs for BE studies impacted by COVID-19」
https://www.raps.org/news-and-
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