Discussions/paper: U.S. - JCO: Accelerated Approval and Oncology Drug Development Timelines

"Based on the US Food and Drug Administration's own standards, our findings, and the criticism of others, it is reasonable to conclude that improvements in AA processes are needed. The US Food and Drug Administration should have an open debate about AA restructuring and perhaps develop an entirely new program that better addresses the context of oncology. Public discussion, augmented by open access to relevant data, is essential."