
FDA Releases Guidance on Critical Path Innovation Meetings
FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.
FDA has released
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.
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