3/1付で米国FDAから「FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments」と題するPress Announcementと共に3点の最終ガイダンスが発出され
タイトルを直訳すれば、「
また本件について、3/1付のRAPSが「FDA finalizes three guidances on cancer trials in line with Biden’s ‘Moonshot’」と題して記事に取り上げています。
開発関係者及び興味のある方は、下記URLsのPress Announcementならびに最終ガイダンス等をご参照くだ
l 3/1付 Press Announcements「FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments」
https://www.fda.gov/news-
l 最終ガイダンス「Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry」
https://www.fda.gov/media/
l 最終ガイダンス「Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry」
https://www.fda.gov/
l 「Inclusion of Older Adults in Cancer Clinical Trials」
https://www.fda.gov/media/
l Federal Register「Inclusion of Older Adults in Cancer Clinical Trials」
https://public-inspection.
l Federal Register「Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics」
https://public-inspection.
l Federal Register「Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics」
Federal Registerhttps://public-
l 3/1付RAPS「FDA finalizes three guidances on cancer trials in line with Biden’s ‘Moonshot’」
https://www.raps.org/news-and-
執筆者について
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
コメント
/
/
/
コメント