This guidance describes the purpose, scope, documentation, and administrative procedures for a Critical Path Innovation Meeting (CPIM), including how to request such a meeting. The CPIM is a means by which the Center for Drug Evaluation and Research (CDER or we) and investigators from industry, academia, patient advocacy groups, and government can communicate to improve efficiency and success in drug development. The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. CDER will identify some of the larger gaps in existing knowledge that requesters might consider addressing in the course of their work. The discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters.
This guidance provides some examples of topics appropriate for a CPIM. It also describes the information that should be provided to CDER in preparation for a meeting and potential outcomes from the CPIM.