Is the Critical Path Innovation Meeting a PDUFA meeting?
The CPIM is not the type of meeting that is described in FDA Guidance(1)(2).The main goal of the CPIM is a collaborative discussion about emerging science, tools and methods to address gaps in drug development.
Must a CPIM occur within a certain time period after it is granted?
There is no required time period within which a CPIM must occur after it is granted. The goal of the CPIM program is to schedule these scientific meetings as soon as feasible. Scheduling is dependent upon the availability of internal and external participants.
It looks like a meeting package is required. But, for the actual meeting, is a Sponsor presentation the expectation?
In advance of a Critical Path Innovation Meeting (CPIM), we request a Preparation Package be sent to us at least 2 weeks in advance of the CPIM date. This preparation package should include:
Objective of the meeting
Presentation slides, if any
Proposed attendees and respective affiliations
Requesters are not required to make a presentation, if they do not choose to do so. The intent of the CPIM is to provide the opportunity for interested parties to discuss scientific activities with FDA staff.
To what extent is this type of meeting (and the individual topics) made public? And, how is that done (e.g., posted to FR)?
FDA will post the topics of each CPIM held on a quarterly basis on the FDA Internet. Often, as a result of posting the meeting topics, others in the scientific community may reach out to collaborate with the requesters. We give requesters the option to post their contact information.
Once a Sponsor submits a request (per process outlined in the guidance), does the Project Manager contact the individual CDER Review Division as needed?
Yes. Once we receive the request from the sponsor, we reach out to FDA staff (including the Review Divisions) with knowledge of the in the topic area.We try to respond to a requester within 14 days of receipt of a meeting request to discuss the proposed CPIM. If a CPIM request is accepted, we invite participation from FDA staff, who attend as time and resources permit.