米国FDA/COVID-19絡みのガイダンス等の発出と更新(2020年12月21日付)
※追記更新(2020.12.23)
12/21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。
l12/21付Updated「Coronavirus (COVID-19) Update: December 21, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-december-21-2020
l12/21付最終ガイダンス「Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry」
https://www.fda.gov/media/144690/download
[12/23付追記更新:上記関連ニュース記事]
l12/22付RAPS「FDA details review timelines as facility assessment-related CRLs pile up」
https://www.raps.org/news-and-articles/news-articles/2020/12/fda-details-review-timelines-as-facility-assessmen
l12/21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
l12/21付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#exhibit1
12/21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
l12/21付Updated「Coronavirus (COVID-19) Update: December 21, 2020」
https://www.fda.gov/news-
l12/21付最終ガイダンス「Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry」
https://www.fda.gov/media/
[12/23付追記更新:上記関連ニュース記事]
l12/22付RAPS「FDA details review timelines as facility assessment-related CRLs pile up」
https://www.raps.org/news-and-
l12/21付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l12/21付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
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