5/7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。
この数週間の緊急通知発出を見る限り、米国の医療状況が相当苦しんでいることが窺われます。
本邦が同様の状況に陥らないことを期待しましょう。
関係者および興味のある方は、下記URLsのガイダンス等をご参照ください。
l5/7付Updated「Coronavirus (COVID-19) Update: Daily Roundup May 7, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-7-2020
l5/7付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l5/7付News Release「Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products」～医療機器の“コロナ詐欺”に関する注意喚起です。
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-combat-fraudulent-covid-19-medical-products
［上記関連ニュース記事］
l5/7付RAPS「COVID-19: FDA fights wave of fraudulent products」
https://www.raps.org/news-and-articles/news-articles/2020/5/fda-fights-wave-of-fraudulent-products-for-covid-1
［以下は人工呼吸器やマスク等の医療機器関係ですが、米国内の本音の状況が垣間見れます。］
l5/7付New「Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers」
https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter
l5/7付Updated「FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic」
https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns-during-covid-19-pandemic
l5/7付Updated「FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-euas-non-niosh-approved-respirators-during-covid-19-pandemic
l5/7付再通知「FDA Reissues Emergency Use Authorization (EUA) for Filtering Facepiece Respirators (FFR) manufactured in China」
https://www.fda.gov/media/136664/download
l5/7付New「Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization - Letter to Health Care Providers」
https://www.fda.gov/medical-devices/letters-health-care-providers/risk-misinterpreting-hydrogen-peroxide-indicator-colors-vapor-sterilization-letter-health-care
l5/7付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l5/7付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2
l5/7付「CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency」～管轄外ですが、動物用医薬品の欠品に関するものです。
https://www.fda.gov/media/137722/download
［米国FDAについての全体に関してのニュース記事］
l5/7付Outsourcing-Pharma.com「Weekly FDA COVID-19 update 」
https://www.outsourcing-pharma.com/Article/2020/05/07/FDA-weekly-COVID-19-updates-and-actions
この数週間の緊急通知発出を見る限り、
本邦が同様の状況に陥らないことを期待しましょう。
関係者および興味のある方は、下記URLsのガイダンス等をご参
l5/7付Updated「Coronavirus (COVID-19) Update: Daily Roundup May 7, 2020」
https://www.fda.gov/news-
l5/7付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l5/7付News Release「Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products」～医療機器の“コロナ詐欺”に関する注意喚起
https://www.fda.gov/news-
［上記関連ニュース記事］
l5/7付RAPS「COVID-19: FDA fights wave of fraudulent products」
https://www.raps.org/news-and-
［以下は人工呼吸器やマスク等の医療機器関係ですが、
l5/7付New「Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers」
https://www.fda.gov/medical-
l5/7付Updated「FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic」
https://www.fda.gov/medical-
l5/7付Updated「FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic」
https://www.fda.gov/medical-
l5/7付再通知「FDA Reissues Emergency Use Authorization (EUA) for Filtering Facepiece Respirators (FFR) manufactured in China」
https://www.fda.gov/media/
l5/7付New「Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization - Letter to Health Care Providers」
https://www.fda.gov/medical-
l5/7付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l5/7付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l5/7付「CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency」～管轄外ですが、
https://www.fda.gov/media/
［米国FDAについての全体に関してのニュース記事］
l5/7付Outsourcing-Pharma.com「Wee
https://www.outsourcing-
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経歴 ※このプロフィールは掲載記事執筆時点での内容となります
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