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A. Meeting Denied

If a meeting request is denied, the FDA will notify the requester in writing according to the
timelines described in Table 1. The FDA’s letter will include an explanation of the reason for
the denial. Denials will be based on a substantive reason, not merely on the absence of a minor
element of the meeting request or meeting package items. For example, a meeting can be denied
because it is premature for the stage of product development or because the meeting package
does not provide an adequate basis for the meeting discussion. Thus, the FDA will generally
deny requests for Type A meetings and Type C meetings to discuss the use of a biomarker as a
new surrogate endpoint that has never been previously used as the primary basis for product
approval that do not include an adequate meeting package in the original reques.

The FDA may also deny requests for meetings that do not have substantive required elements described in section
V., Meeting Requests. A subsequent request to schedule the meeting will be considered as a new
request (i.e., a request that merits a new set of time frames as described in section III., Meeting 296 Types).