FDA Clarifies Tool for Expediting Drug Development; Issues draft guidance for Critical Path Innovation Meetings – Guidance for Industry

14.11.19On October 08, 2014, the FDA issued a draft guidance for industry entitled “Critical Path Innovation Meetings.” The Critical Path Innovation Meetings (CPIM) provides an opportunity for FDA’s Center for Drug Evaluation and Research (CDER) to discuss a proposed methodology or technology with the meeting requester in order to discuss and provide general advice on how to improve drug development and efficiency by outlining areas they may want to address during their work. Importantly “the discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters.” The draft guidance describes the purpose and scope of a CPIM and how to request a meeting.

The guidance lists a few examples of potential topics for a CPIM, which include:

  • “Biomarkers in the early phase of development and not yet ready for the Biomarker Qualification Program (BQP)…
  • 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…
  • Innovative conceptual approaches to clinical trial design and analysis…”

The guidance also clarifies that FDA will not provide “regulatory advice on specific product development programs at a CPIM.”

Comments on this guidance are open to FDA until December 8, 2014.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417627.pdf

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