How FDA Is Working to Improve Oncology Drug Development
The US Food and Drug Administration (FDA) is trying to improve how oncology drugs arrive in the clinic by making changes to the accelerated approval process, making a move towards optimal rather than maximally tolerated doses in drug development, and also making clinical trials more accessible. All these points were discussed by Richard Pazdur, MD, head of the FDA's Oncology Center of Excellence at a special session during the recent annual meeting of the American Society for Clinical Oncology (ASCO).
@abhilan Mostly this stemmed from the very fast development of many new immune checkpoint inhibitors. Pazdur wrote last year that the "unbridled and rapid growth of checkpoint inhibitors has led to a 'Wild West' of drug development, featuring a stampede of commercial sponsors, clinical trials, and redundant development plans