FDA Issues Draft Guidance on Critical Path Innovation Meetings

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 10-14-2014 10:05

The US Food and Drug Administration has issued a draft guidance, Critical Path Innovation Meetings, to describe the purpose, scope, documentation, and administrative procedures for a Critical Path Innovation Meeting (CPIM),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) 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 the FDA and CPIM requesters.

This draft guidance provides some examples of topics appropriate for a CPIM.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. Some examples of potential topics include: a discussion of the potential of proposed biomarkers; clinical outcome assessments in the early phase of development and not yet ready for the Clinical Outcome Assessment Qualification Program; natural history study designs and implementation; emerging technologies or new uses of existing technologies: and innovative conceptual approaches to clinical trial design and analysis.

In the draft guidance, the FDA specifies that it  will not give regulatory advice on specific product development programs at a CPIM. Meetings relating to a specific drug development program should be requested through the appropriate review division in accordance with the FDA Guidance for Industry Formal Meetings  Between the FDA and Sponsors or Applicants. The CPIM is not intended to replace meetings that should be held through formal DDT qualification programs. Requesters interested in discussions related to the Drug Development Tools (DDT) qualification programs should contact the relevant  DDT qualification program directly. CPIMs are not intended to discuss therapeutic product-specific data or result in binding agreements.

Source: FDA


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