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OTAT Type A Meetings

Type A meetings are reserved for discussions necessary for an otherwise stalled product development program to proceed or to address an important safety issue. However, disagreement with OTAT, for example, does not necessarily constitute a stalled program.

Submission of Type A 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 are 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 A Meetings

OTAT Response to Meeting Request**

14 days from receipt

Meeting Scheduling or WRO issued***

30 days from receipt

Meeting package due to OTAT

At the time of request

Meeting Length granted

60 minutes

OTAT Preliminary Response to questions in the package to Sponsor (for teleconferences or face-to-face meetings)

NLT* 2 days before the meeting

Sponsor’s Response to FDA preliminary response (for teleconferences or face-to-face meetings)

NLT than 24 hours before the meeting

*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.

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