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のガイダンス等をご参照ください。
l3/30付Updated：全体ウェブサイト「Coronavirus Disease 2019 (COVID-19) 」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l3/30付News Release「FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation」
https://www.fda.gov/news-events/press-announcements/fda-signing-covid-19-emergency-relief-bill-including-landmark-over-counter-drug-reform-and-user-fee
l3/29付Updated「Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-further-steps-help-mitigate-supply-interruptions-food-and
l3/30付Updated「Coronavirus (COVID-19) Update: Daily Roundup March 30, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-30-2020
l3/30付Updated「Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expedites-review-diagnostic-tests-combat-covid-19
l3/30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
l3/29付CDRHガイダンス「Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/136533/download
［上記関連ニュース記事］
l3/30付RAPS「FDA Issues and Expands EUA for Respirator Decontamination System」
https://www.raps.org/news-and-articles/news-articles/2020/3/fda-issues-and-expands-eua-for-respirator-decontam
l3/30付CDRHガイダンス「Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency」
https://www.fda.gov/media/136540/download
［上記関連ニュース記事］
l3/30付RAPS「FDA Eases Regulatory Requirements on Surgical Gowns, Gloves」
https://www.raps.org/news-and-articles/news-articles/2020/3/fda-eases-regulatory-requirements-on-surgical-gown
l3/30付「FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation」
https://www.fda.gov/news-events/press-announcements/fda-signing-covid-19-emergency-relief-bill-including-landmark-over-counter-drug-reform-and-user-fee
［全体ニュース記事］
l3/30付RAPS「What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of Commercial Tests」
https://www.raps.org/news-and-articles/news-articles/2020/3/what-went-wrong-with-covid-19-testing-fda-points-t
［関連ニュース記事］
l3/30付RAPS「FDA EUA Allows States to Receive Unapproved COVID-19 Treatments」
https://www.raps.org/news-and-articles/news-articles/2020/3/fda-eua-allows-states-to-receive-unapproved-covid
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
l3/30付Updated：全体ウェブサイト「Coronavi
https://www.fda.gov/emergency-
l3/30付News Release「FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation」
https://www.fda.gov/news-
l3/29付Updated「Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products」
https://www.fda.gov/news-
l3/30付Updated「Coronavirus (COVID-19) Update: Daily Roundup March 30, 2020」
https://www.fda.gov/news-
l3/30付Updated「Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19」
https://www.fda.gov/news-
l3/30付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l3/29付CDRHガイダンス「Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers 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］
l3/30付RAPS「FDA Issues and Expands EUA for Respirator Decontamination System」
https://www.raps.org/news-and-
l3/30付CDRHガイダンス「Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency」
https://www.fda.gov/media/
［上記関連ニュース記事］
l3/30付RAPS「FDA Eases Regulatory Requirements on Surgical Gowns, Gloves」
https://www.raps.org/news-and-
l3/30付「FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation」
https://www.fda.gov/news-
［全体ニュース記事］
l3/30付RAPS「What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of Commercial Tests」
https://www.raps.org/news-and-
［関連ニュース記事］
l3/30付RAPS「FDA EUA Allows States to Receive Unapproved COVID-19 Treatments」
https://www.raps.org/news-and-
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