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  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Critical Path Innovation Meetings (CPIM)
  1. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Critical Path Innovation Meetings (CPIM)

Watch a video about the CPIM program

The Critical Path Innovation Meeting (CPIM) was developed by CDER to address issues in drug development identified in the 2004 FDA publication, Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products Report. The report identified several areas of product development in need of improvement, including “technical methods such as animal or computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques,” and cited a need “to create better tools for developing medical technologies [and] a knowledge base built not just on ideas from biomedical research, but on reliable insights into the pathway to patients.”

The CPIM is a means by which the Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, scientific consortia, 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 during their work. CDER expects to become more familiar with prospective innovations in drug development, broadening its regulatory perspective. CPIM discussions are non-regulatory, drug product-independent and nonbinding on both FDA and CPIM requesters.

The CPIM is a forum for FDA and stakeholders to discuss potential scientific advancements in drug development.  The CPIM does not substitute for formal pre-IND, IND, NDA, BLA, or other regulatory meetings. The CPIM is not a venue for entities to market commercial products to or seek endorsement from the FDA. The CPIM does not permit an in-depth review of data by the FDA.

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Potential topics for a CPIM include, but are not limited to, the following:
  • 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

Critical Path Innovation Meeting Request Form found here.

CDER will consider the suitability of a request for a CPIM and may suggest other means to address issues presented by requesters, inside and outside FDA, as appropriate. If a CPIM is suitable, CDER will request a preparation package in advance of the meeting.

The preparation package should be sent electronically to CPIMInquiries@fda.hhs.gov and contain the following:

  • Objective of the meeting
  • Proposed agenda
  • Presentation slides, if any
  • Proposed attendees and respective affiliations

For additional information about the CPIM Program, please view the informational webinar and video, or download the podcast.

If you have any questions about the CPIM Program, please contact CPIMInquiries@fda.hhs.gov.

For additional information about other opportunities for engagement with the FDA, please visit the list of other FDA meeting options. 

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