Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU

• Những tác giả chính: Ebru Demirci (Tác giả), Grace Omes‐Smit (Tác giả), Alex Zwiers (Tác giả)
• Định dạng: Sách
• Được phát hành: Wiley, 2023-07-01T00:00:00Z.
• Những chủ đề: article
• Truy cập trực tuyến: Connect to this object online.

Abstract The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization: (i) drug development (fast track designation (FTD), b...