米国FDA/COVID-19絡みのガイダンス等の発出と更新(2021年1月26日付)
※追記更新(2021.01.28)
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。
l1/26付Updated「Coronavirus (COVID-19) Update: January 26, 2021」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-january-26-2021
l1/26付News Release「Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-place-all-alcohol-based-hand-sanitizers-mexico-import
[1/28付追記更新:上記関連ニュース記事]
l1/27付RAPS「FDA puts all Mexican hand sanitizers on import alert」
https://www.raps.org/news-and-articles/news-articles/2021/1/fda-puts-all-mexican-hand-sanitizers-on-import-ale
l「CDER’s Work to Meet User Fee Goals During the Pandemic」~パンデミック中の業務評価です。査察については減少したようです。
https://www.fda.gov/industry/fda-user-fee-programs/cders-work-meet-user-fee-goals-during-pandemic
[上記関連ニュース記事]
l1/26付RAPS「Inspections down in 2020, but CDER hit most goal dates」
https://www.raps.org/news-and-articles/news-articles/2021/1/inspections-down-in-2020-but-cder-hit-most-goal-da
l1/26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-serological
l1/26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#appendixasurgicalmasks
1/26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
l1/26付Updated「Coronavirus (COVID-19) Update: January 26, 2021」
https://www.fda.gov/news-
l1/26付News Release「Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers」
https://www.fda.gov/news-
[1/28付追記更新:上記関連ニュース記事]
l1/27付RAPS「FDA puts all Mexican hand sanitizers on import alert」
https://www.raps.org/news-and-
l「CDER’s Work to Meet User Fee Goals During the Pandemic」~パンデミック中の業務評価です。
https://www.fda.gov/industry/
[上記関連ニュース記事]
l1/26付RAPS「Inspections down in 2020, but CDER hit most goal dates」
https://www.raps.org/news-and-
l1/26付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l1/26付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
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