4/24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。
l4/24付Updated「Coronavirus (COVID-19) Update: Daily Roundup April 24, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-24-2020
l4/23付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l4/24付News Release「Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-importance-close-patient-supervision-label-use
l4/24付ガイダンス「Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/137307/download
［上記関連ニュース記事］
l4/24付RAPS「FDA seeks to expand use of remote digital pathology devices amid pandemic」
https://www.raps.org/news-and-articles/news-articles/2020/4/fda-seeks-to-expand-use-of-remote-digital-patholog
l4/24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
l4/24付Statement「Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-importance-close-patient-supervision-label-use
l4/24付「FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems」～EUについては4/24付GMP Platformトピック「EMA／Coronavirus (COVID-19) 関連情報（2020年4月23日付）」をご参照ください。
https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or
［上記関連ニュース記事］
l4/24付RAPS「FDA warns against malaria drugs for COVID-19 outside hospital, clinical settings」
https://www.raps.org/news-and-articles/news-articles/2020/4/fda-warns-against-malaria-drugs-for-covid-19-outsi
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
l4/24付Updated「Coronavirus (COVID-19) Update: Daily Roundup April 24, 2020」
https://www.fda.gov/news-
l4/23付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l4/24付News Release「Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems」
https://www.fda.gov/news-
l4/24付ガイダンス「Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/
［上記関連ニュース記事］
l4/24付RAPS「FDA seeks to expand use of remote digital pathology devices amid pandemic」
https://www.raps.org/news-and-
l4/24付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l4/24付Statement「Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems」
https://www.fda.gov/news-
l4/24付「FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems」～EUについては4/24付GMP Platformトピック「EMA／Coronavirus (COVID-19) 関連情報（2020年4月23日付）」をご参照ください。
https://www.fda.gov/drugs/
［上記関連ニュース記事］
l4/24付RAPS「FDA warns against malaria drugs for COVID-19 outside hospital, clinical settings」
https://www.raps.org/news-and-
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