RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting TimingsFrom the FDA directive on " Considerations for Discussion of a New Surrogate Endpoint(s) at a Type C PDUFA Meeting Request"
"FDA and industry believe that early consultation between review teams and sponsors is important for development programs where the sponsor intends to use a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use. Early consultation in the drug development program allows the review team to consult with FDA senior management to evaluate the sponsor’s proposal before providing advice regarding the proposed biomarker as a new surrogate endpoint to support accelerated or traditional approval. Requests to engage with FDA on this topic will be considered a Type C meeting request. The purpose of this meeting is to discuss the feasibility of the surrogate as a primary endpoint, and identify any gaps in knowledge and how they might be addressed. The outcome of this meeting may require further investigation by the sponsor and discussion and agreement with the agency before the surrogate endpoint could be used as the primary basis for product approval. To qualify for this consultation, these Type C meeting requests must be accompanied by the complete meeting background package at the time the request is made that includes preliminary human data indicating impact of the drug on the biomarker at a dose that appears to be generally tolerable. The remaining meeting procedures as described in Section I.H of this document [for formal PDUFA meetings between sponsors and FDA] will apply. 1