米国FDA/COVID-19絡みのガイダンス等の発出と更新(2021年5月19日付)
2021/05/20
ニューストピックス

5/19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。
l5/19付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l5/19付FDA In Brief「FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available」~Pfize社ワクチンについて、希釈前の解凍されたバイアルの冷蔵庫温度での最大1か月間の保管期間の申請です。
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time-refrigerator-storage-thawed-pfizer-biontech-covid-19-vaccine :
l5/19付FDA In Brief「FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination」~ワクチン接種後免疫または保護評価のための抗体検査結果の使用に反対するというアドバイスです
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-advises-against-use-sars-cov-2-antibody-test-results-evaluate-immunity-or-protection
l5/19付Notice「Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication」
https://www.fda.gov/medical-devices/safety-communications/antibody-testing-not-currently-recommended-assess-immunity-after-covid-19-vaccination-fda-safety
l5/19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
l5/9付Topic「FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments」
https://www.fda.gov/drugs/drug-safety-and-availability/fda-receives-hhs-grant-expand-cure-id-platform-covid-19-treatments
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
l5/19付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l5/19付FDA In Brief「FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available」~Pfize社ワクチンについて、
https://www.fda.gov/news-
l5/19付FDA In Brief「FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination」~
https://www.fda.gov/news-
l5/19付Notice「Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication」
https://www.fda.gov/medical-
l5/19付Updated「「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l5/9付Topic「FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments」
https://www.fda.gov/drugs/
コメント
/
/
/
この記事へのコメントはありません。
コメント