FDA Releases Guidance on Critical Path Innovation Meetings

FDA has released draft guidance on the purpose, scope, documentation, and administrative procedures for a Critical Path Innovation Meeting (CPIM). The guidance includes how to request such a CPIM meeting, which is the way the Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, patient advocacy groups, and government can communicate to improve efficiency and success in drug development.

A CPIM may be used as a way for industry to discuss a methodology or technology with CDER so that CDER may identify gaps in existing knowledge that requesters might consider addressing in the course of their work. According to FDA, discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters.

The guidance provides some examples of topics appropriate for a CPIM. It also describes information that should be provided to CDER in preparation for a meeting and potential outcomes from the CPIM.