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OTAT Type C Meetings

Type C meeting requests are evaluated on a case-by-case basis to determine if a meeting is needed or if the feedback the sponsor is seeking can instead be provided via an amendment to the IND.

Submission of Type C meeting requests to OTAT

The sponsor should submit the meeting request as an amendment to the existing IND. The meeting request should include a list of the specific objectives of the meeting and a list of questions [grouped by discipline, e.g., Chemistry, Manufacturing, and Controls (CMC), pharmacology / toxicology, clinical, statistical].

Courtesy emails to the Regulatory Project Manager (RPM) for the IND and to OTATRPMS@fda.hhs.gov regarding submission of the meeting request to the file is greatly appreciated.

OTAT does not send an acknowledgement email or letter following OTAT’s receipt of a meeting request. However, by the timelines described in the Table, OTAT will send the decision to grant or deny the meeting request, along with the meeting date, if granted, or reasons for denial.

Table: Timelines for Type C Meetings

OTAT Response to Meeting Request**

21 days

Meeting Scheduling or WRO issued***

75 days

Meeting package due to OTAT****

At least 47 days before the scheduled date of the meeting or WRO

Meeting Length

60 minutes

OTAT Preliminary Response to questions in the package to Sponsor (for teleconference)

NLT* 5 days before the meeting

Sponsor’s Response to FDA preliminary response (for teleconference)

NLT 3 days after receipt of Preliminary Responses

*NLT – No Later Than
Source: Table information from the Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products Guidance for Industry
**Calendar days from FDA receipt of the meeting request to the date that OTAT will respond with the decision to grant or deny the meeting, as well as specifying the format and date of the meeting, if granted.
*** Calendar days from FDA receipt of the meeting request to date the meeting will be held, or the WRO will be issued.
****For Type C meetings that are requested as early consultations on the use of a new surrogate endpoint to be used as the primary basis for product approval in a proposed context of use, the meeting package is due at the time of the meeting request.

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