Rana Ezzeddine is Director, Regulatory Affairs (Oncology), AstraZeneca. She has more than sixteen years of post-Ph.D. oncology drug development experience, with half of these years leading a global team of statisticians and programmers. She has strong knowledge of regulatory guidelines and a solid experience with global regulatory submissions.
Conditional oncology drug approvals: A sponsor’s perspective on the evolving landscape of FDA accelerated approvals
The FDA’s accelerated approval (AA) pathway is an important regulatory mechanism that allows patients with serious or life-threatening conditions, potentially earlier access to treatments than under a standard, regular approval development pathway...