2/9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。
l2/9付News Release「Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0
l2/9付News Release「Coronavirus (COVID-19) Update: February 9, 2021」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-february-9-2021
l2/9付Updated「Coronavirus (COVID-19) | CBER-Regulated Biologics」
https://www.fda.gov/vaccines-blood-biologics/industry-biologics/coronavirus-covid-19-cber-regulated-biologics
l2/9付New「COVID-19 Vaccine Safety Surveillance」
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance
l2/9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-molecular
l2/9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
l2/9付New「Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers」
https://www.fda.gov/medical-devices/letters-health-care-providers/using-ventilator-splitters-during-covid-19-pandemic-letter-health-care-providers
［全体に関するニュース記事］
l2/9付Outsourcing-Pharma.com「Latest FDA COVID-19 updates and activity 」
https://www.outsourcing-pharma.com/Article/2021/02/09/Latest-FDA-COVID-19-updates-and-activity
l2/9付RAPS「Trump HHS advisor pressured FDA, says House subcommittee」～トランプ前大統領が政府のコロナウイルス対策委員会に圧力をかけているようです。
下記Press Releaseもニュース記事末尾にリンクされています。
https://www.raps.org/news-and-articles/news-articles/2021/2/trump-hhs-advisor-pressured-fda-says-house-subcomm
l2/8付The House Select Subcommittee on the Coronavirus Crisis「Select Subcommittee Releases New Evidence Of Trump Administration’s Political Meddling In Coronavirus Guidance, Testing And Treatments」
https://coronavirus.house.gov/news/press-releases/select-subcommittee-releases-new-evidence-trump-administration-s-political
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
l2/9付News Release「Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19」
https://www.fda.gov/news-
l2/9付News Release「Coronavirus (COVID-19) Update: February 9, 2021」
https://www.fda.gov/news-
l2/9付Updated「Coronavirus (COVID-19) | CBER-Regulated Biologics」
https://www.fda.gov/vaccines-
l2/9付New「COVID-19 Vaccine Safety Surveillance」
https://www.fda.gov/vaccines-
l2/9付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l2/9付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
l2/9付New「Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers」
https://www.fda.gov/medical-
［全体に関するニュース記事］
l2/9付Outsourcing-Pharma.com「Lat
https://www.outsourcing-
l2/9付RAPS「Trump HHS advisor pressured FDA, says House subcommittee」～
下記Press Releaseもニュース記事末尾にリンクされています。
https://www.raps.org/news-and-
l2/8付The House Select Subcommittee on the Coronavirus Crisis「Select Subcommittee Releases New Evidence Of Trump Administration’s Political Meddling In Coronavirus Guidance, Testing And Treatments」
https://coronavirus.house.gov/
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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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