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Facilitate Scientific Collaborations

FDA Critical Path Innovation Meeting

A Critical Path Innovation Meeting (CPIM) is a meeting to discuss the science, medicine, and/or regulatory aspects related to innovation in therapy development. The meeting is between FDA staff and individuals from industry, academia, and/or groups like your own. 

  • CPIM provides an opportunity to have an open scientific discussion and to hear the FDA’s perspective on the method, approach, or technology being developed.
  • The goal is to improve the efficiency and success in drug development. 
  • If a CPIM is accepted, the FDA may invite subject matter experts from other Centers in the FDA, including Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH).
  • Materials to be presented at the CPIM are requested 2 weeks prior to the CPIM.
  • The FDA staff participating in the CPIM meet 1 week prior to the actual CPIM to review the information. Other experts may be identified.
  • The meeting lasts about 90 minutes.
  • A brief, high level summary will be written by the Office of Translational Sciences  and shared with the person who requested the meeting.
  • Topic area is added to the CPIM website. 
  • Outcomes include:
    • CPIM staff may help your group connect with other investigators sharing similar medical development challenges.
    • FDA may facilitate discussions with review divisions or other FDA scientific staff.
    • Recommendations may include convening a public workshop, collaborating with other groups.
    • May lead to technology transfer activities such as a research collaborative agreement or a Cooperative Research and Development Agreement (CRADAs ) between investigators and FDA.
  • CPIM topics include:
    • Rare disease progression studies
    • Biomarkers as clinical trial endpoints
    • Therapy development tools
    • Innovative trial designs
    • Clinical trial networks
    • Natural History Studies
    • Clinical outcome assessment development
    • Databases
    • Registries
  • FDA Critical Path Innovation Meetings provides more detail about CPIMs.
  • If you have any questions about the CPIM Program, please contact CPIMInquiries@fda.hhs.gov . 

Resources

Organize In-Person Scientific Meetings
List of Registries National Institutes of Health Clinical Center (link)
Contacts and Special Interests for R13 and U13 Applications National Institutes of Health (NIH) (link)
NIH Support for Scientific Conferences (R13 and U13) National Institutes of Health (NIH) (link)
FAQs about R13 grants National Institutes of Health (NIH) (link)
NIH Programs Supporting Collaboration
Office of Advocacy Relations National Cancer Institute (NCI) (link)
Patient/Community Engagement & Health Information National Center for Advancing Translational Sciences (NCATS) (link)
Work with NCATS National Center for Advancing Translational Sciences (NCATS) (link)
Rare Disease Clinical Research Network (RDCRN) National Center for Advancing Translational Sciences (NCATS) (link)
RDCRN Funding Information National Center for Advancing Translational Sciences (NCATS) (link)
RDCRN Conference on Clinical Research for Rare Diseases (CCRRD) National Center for Advancing Translational Sciences (NCATS) (link)
FDA Critical Path Innovation Meeting
Cooperative Research and Development Agreement (CRADAs) U. S. Food and Drug Administration (FDA) (link)
FDA Critical Path Innovation Meetings U. S. Food and Drug Administration (FDA) (link)
Video on the Critical Path Innovation Meeting (CPIM) Program U. S. Food and Drug Administration (FDA) (link)
Other FDA Meeting Opportunities
Patients Ask FDA U. S. Food and Drug Administration (FDA) (link)
Patient Listening Sessions U. S. Food and Drug Administration (FDA) (link)