A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU

• Auteurs principaux: Fabiany da Costa Gonçalves (Auteur), Ebru Demirci (Auteur), Alex Zwiers (Auteur)
• Format: Livre
• Publié: Wiley, 2022-08-01T00:00:00Z.
• Sujets: article
• Accès en ligne: Connect to this object online.

Abstract The aim of this study was to assess the effect of expedited regulatory approval programs used by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), type of product (small molecule or biotechnology‐derived product) and consulting scientific advisory committees...