5/10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。
l5/10付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l5/10付New Release「Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic」～今まで16歳以上とされていたPfizer社ワクチンですが、12-15歳まで拡大しました。
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use
l5/10付FDA In Brief「FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines」
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-hold-meeting-its-vaccines-and-related-biological-products-advisory-committee-discuss
［上記関連ニュース記事］
l5/10付RAPS「FDA authorizes Pfizer-BioNTech vaccine in children 12-15」
https://www.raps.org/news-and-articles/news-articles/2021/5/vrbpac-to-meet-next-month-on-covid-vaccines-in-chi
l5/10付Updated「In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
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
l5/10付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l5/10付New Release「Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic」～今まで16歳以上とされていたPfizer
https://www.fda.gov/news-
l5/10付FDA In Brief「FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines」
https://www.fda.gov/news-
［上記関連ニュース記事］
l5/10付RAPS「FDA authorizes Pfizer-BioNTech vaccine in children 12-15」
https://www.raps.org/news-and-
l5/10付Updated「In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2」
https://www.fda.gov/medical-
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