Ian Martin is Senior Director, Regulatory Affairs, at AstraZeneca. He is an experienced Senior Director of Regulatory Affairs with a demonstrated history of working in the pharmaceuticals industry. He has experience of working with Small Molecules and Biotechnology across a variety of TAs, and is skilled in EU Regulatory Requirements, Drug Development, Marketing Applications and Life Cycle Maintenance activities.
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...