Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures

• Main Authors: Nishimura T (Author), Tada H (Author), Nakagawa M (Author), Teramukai S (Author), Matsui S (Author), Fukushima M (Author)
• Format: Book
• Published: Centro de Investigaciones y Publicaciones Farmaceuticas, 2006-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Objective: The objective of this study was to identify problems in the approval, pharmacovigilance, and post-approval regulatory decision-making procedures involving gefitinib and to propose countermeasures to prevent further drug-induced suffering in Japan in the future. Methods: We comprehensively...