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

• Główni autorzy: Ebru Demirci (Autor), Grace Omes‐Smit (Autor), Alex Zwiers (Autor)
• Format: Książka
• Wydane: Wiley, 2023-07-01T00:00:00Z.
• Hasła przedmiotowe: article
• Dostęp online: 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...