12/10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。
l12/10付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l12/10付Updated「Coronavirus (COVID-19) Update: December 10, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-december-10-2020
l12/10付Updated「Coronavirus Treatment Acceleration Program (CTAP)」
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
l12/10付Updated「FDA updates on hand sanitizers consumers should not use」
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
l12/10付Updated「Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-holds-advisory-committee-meeting-discuss-authorization-covid-19
l12/10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
l12/10付Updated「COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2
l12/10付Updated「COVID-19 Testing Supplies: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-testing-supplies-faqs-testing-sars-cov-2
l12/10付Updated「COVID-19 Test Settings: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-settings-faqs-testing-sars-cov-2
l12/10付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-and-emergency-use-authorizations-faqs-testing-sars-cov-2
l12/10付Updated「Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2
l12/10付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-viral-transport-media-during-covid-19
［全体に関するニュース記事］
l12/10付RAPS「Pfizer COVID vax gets thumbs up from FDA's VRBPAC」～VRBPACとは“FDA’s Vaccines and Related Biological Products Advisory Committee”、いわゆる専門委員会のことです。
https://www.raps.org/news-and-articles/news-articles/2020/12/thumbs-up-on-pfizer-covid-vax-from-fdas-vrbpac
l12/9付BioPharmaReporter.com「How prepared are the US authorities for safe and expedient COVID-19 vaccine distribution?」
https://www.biopharma-reporter.com/Article/2020/12/09/How-prepared-are-the-US-authorities-for-safe-and-expedient-COVID-19-vaccine-distribution
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
l12/10付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l12/10付Updated「Coronavirus (COVID-19) Update: December 10, 2020」
https://www.fda.gov/news-
l12/10付Updated「Coronavirus Treatment Acceleration Program (CTAP)」
https://www.fda.gov/drugs/
l12/10付Updated「FDA updates on hand sanitizers consumers should not use」
https://www.fda.gov/drugs/
l12/10付Updated「Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data」
https://www.fda.gov/news-
l12/10付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
l12/10付Updated「COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l12/10付Updated「COVID-19 Testing Supplies: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l12/10付Updated「COVID-19 Test Settings: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l12/10付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l12/10付Updated「Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l12/10付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
［全体に関するニュース記事］
l12/10付RAPS「Pfizer COVID vax gets thumbs up from FDA's VRBPAC」～VRBPACとは“FDA’s Vaccines and Related Biological Products Advisory Committee”、いわゆる専門委員会のことです。
https://www.raps.org/news-and-
l12/9付BioPharmaReporter.com「How prepared are the US authorities for safe and expedient COVID-19 vaccine distribution?」
https://www.biopharma-
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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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