Expedited Approval Pathway Concept Draws Strong Support But Different Proposals

Growing momentum for finding new ways to speed development and approval of drugs for serious diseases has led to draft legislation in the Senate and efforts under the Innovation Initiative at FDA. Yet, debate at a recent cancer research meeting reflected the challenges that lay ahead, and the diverging viewpoints that will have to be balanced, in creating any new approval mechanism.

At the Nov. 10 Conference on Clinical Cancer Research in Washington, D.C., a panel of agency representatives and stakeholders collectively proposed an expedited development pathway model for drugs with early evidence of large treatment effects