Guidance for Industry Formal Meetings Between the

Guidance for Industry
Formal Meetings Between the
FDA and Sponsors or
Applicants

V. ASSESSING MEETING REQUESTS
The CBER or CDER division director or designee who receives a meeting request will determine
whether to hold the meeting and will respond to the sponsor or applicant by granting or denying
the meeting within 14 days of receipt of the request for Type A meetings and within 21 days for
Type B and Type C meetings.
A. Meeting Denied
If a meeting request is denied, notification to the sponsor or applicant 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. 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).

https://www.fda.gov/media/72253/download