Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals

• Glavni autori: Hayase Hakariya (Autor), Frank Moriarty (Autor), Akihiko Ozaki (Autor), Shai Mulinari (Autor), Hiroaki Saito (Autor), Tetsuya Tanimoto (Autor)
• Format: Knjiga
• Izdano: Wiley, 2024-07-01T00:00:00Z.
• Teme: article
• Online pristup: Connect to this object online.

Abstract Regulatory authorities must balance ensuring evidence of efficacy and safety of new drugs. Various regulatory pathways, such as the accelerated approval program in the United States (US), allow authorities to quickly approve drugs for severely ill patients by granting market authorization b...