Australian access to FDA-approved breakthrough therapy designation medicines: a 10-year review

• Main Authors: Senthil Lingaratnam (Author), Safeera Yasmeen Hussainy (Author), Alexandra Murphy (Author), Cale Perrin (Author), Melbin Samuvel (Author), Elahe Mehrvarz (Author), Chiao Xin Lim (Author), John Zalcberg (Author)
• Format: Book
• Published: Taylor & Francis Group, 2024-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Background Regulatory pathways adopted by the United States Food Drug and Administration (FDA) and Australian Therapeutic Goods Administration (TGA) enable expedited approval of medicines that are thought to offer significant clinical advantage over existing options for severe diseases.Objectives To...