2021.02.23.TUE

その他

米国FDA/COVID-19絡みのガイダンス等の発出と更新(2021年2月22日付)

この記事を印刷する

執筆者:古田土 真一

※追記更新(2021.02.24)
※追記更新(2021.02.26)

2/22
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。
 
l2/22UpdatedCOVID-19 Vaccines
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
 
l2/22News ReleaseCoronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-policies-guide-medical-product-developers-addressing-virus
 
[上記関連ニュース記事]
l2/22RAPSFDA unveils plans to tackle COVID variants
https://www.raps.org/news-and-articles/news-articles/2021/2/fda-unveils-plans-to-tackle-covid-variants
 
l2/22付最終ガイダンス「Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency
https://www.fda.gov/media/146173/download
 
l2/22付改訂ガイダンス「COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
https://www.fda.gov/media/137926/download
 

2/24付追記更新:上記関連ニュース記事]

l2/23RAPSFDA's COVID therapeutics, mAbs guidance accounts for variants
https://www.raps.org/news-and-articles/news-articles/2021/2/fdas-covid-therapeutics-mabs-guidance-accounts-for
 
l2/23Outsourcing-Pharma.comDeveloping vaccines and therapeutics for virus variants: FDA releases new guidance

https://www.outsourcing-pharma.com/Article/2021/02/23/Developing-vaccines-and-therapeutics-for-virus-variants-FDA-releases-new-guidance
 
l2/23BioPharmaReporter.comFindings of new study may help inform the design of next-generation COVID-19 vaccines, as new variants emerge

https://www.biopharma-reporter.com/Article/2021/02/23/Findings-of-new-study-may-help-inform-the-design-of-next-generation-COVID-19-vaccines-as-new-variants-emerge



l2/22付最終ガイダンス「Emergency Use Authorization for Vaccines to Prevent COVID-19
https://www.fda.gov/media/142749/download
 
[上記関連ニュース記事]
l2/22RAPSFDA updates EUA guidance, addressing vaccines against COVID variants
https://www.raps.org/news-and-articles/news-articles/2021/2/fda-updates-eua-addressing-vaccines-against-covid
 

2/26付追記更新:上記関連ニュース記事

l2/25BioPharmaReporter.comPfizer and BioNTech start trialing booster shot for COVID-19 vaccine
https://www.biopharma-reporter.com/Article/2021/02/25/Pfizer-and-BioNTech-start-trialing-booster-shot-for-COVID-19-vaccine
 
l2/22American Pharmaceutical ReviewFDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

https://www.americanpharmaceuticalreview.com/Specialty/Formulation_Development/1315-News/573477-FDA-Issues-Policies-to-Guide-Medical-Product-Developers-Addressing-Virus-Variants/?catid=6262



l2/22付最終ガイダンス「Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests
https://www.fda.gov/media/146171/download
 
[上記関連ニュース記事]
l2/22RAPSCOVID test developers get variant-related FDA guidance
https://www.raps.org/news-and-articles/news-articles/2021/2/covid-test-developers-get-variant-related-fda-guid
 
l2/22UpdatedIn Vitro Diagnostics EUAs
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-molecular
 
l2/22UpdatedPersonal Protective Equipment EUAs
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#exhibit1
 
l2/22UpdatedNotifications 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
 
l2/22UpdatedRemoval 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
 
[全体に関するニュース記事]
l2/22BioPharmaReporter.comPfizer/BioNTech to trial COVID-19 vaccine in pregnant women and children
https://www.biopharma-reporter.com/Article/2021/02/22/Pfizer-BioNTech-to-trial-COVID-19-vaccine-in-pregnant-women-and-children
 
l2/22BioPharmaReporter.comPfizer/BioNTech COVID-19 vaccine can be stored at standard freezer temperature for 2 weeks, say companies
https://www.biopharma-reporter.com/Article/2021/02/22/Standard-freezer-temperatures-for-Pfizer-BioNTech-COVID-19-vaccine
 

1 / 1ページ

  • arrow03_off.png先頭
  • 1
  • 最後arrow01_off.png

古田土 真一

古田土 真一

GMDPコンサルタント(Pharmaceutical Quality Science Advisor)

1979年より田辺製薬(株)(現田辺三菱製薬)にて合成探索研究、プロセス・工業化研究、CMCプロジェクト開発、治験薬QA、コーポレートQAを歴任。2008年より武州製薬(株)にてQA/QCの管理監督。2009年より中外製薬(株)にて治験薬・医薬品のQA業務・品質システムを改革推進。2013年よりアステラス・アムジェン・バイオファーマ(株)にてCMC・Supply Chain・QAの長として業務構築。2015年より三井倉庫ホールディングス(株)にてヘルスケア製品の事業開発アドバイザーとして業務構築し2020年3月に退職。同2015年より (国立研究開発法人) 国立精神・神経医療研究センター/トランスレーショナル・メディカルセンター臨床研究支援部アドバイザーとして医薬品開発を支援中。
医薬品の開発から保管・流通までを品質の側面から一貫した経験を活かし、2020年4月からはフリーのGMDPコンサルタントとしてGood Practicesの支援依頼に対応中。