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
l4/5付最終ガイダンス「Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry」
https://www.fda.gov/media/
[上記関連ニュース記事]
l4/5付RAPS「FDA offers guidance on generic drug development during COVID」
https://www.raps.org/news-and-
l4/5付Updated「In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2」
https://www.fda.gov/medical-
l4/5付Updated「In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2」
https://www.fda.gov/medical-
l4/5付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l4/5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-