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:
- 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 .