OTP Type D Meetings

Type D Meetings should be limited to one or two focused topics, should not exceed three to five questions in total, and should not require input from more than three disciplines or divisions.  If the sponsor has more than two focused topics, a highly complex issue is raised, or a follow-up question that raises a new issue after a formal meeting (i.e., more than just a clarifying question about an FDA response from a prior meeting), then a Type B or C Meeting should be considered instead of a Type D Meeting. A Type B or C Meeting should also be scheduled in lieu of multiple Type D Meetings scheduled in temporal proximity. 

Type D Meeting requests are evaluated on a case-by-case basis to determine if the meeting meets the criteria for the meeting type.

Submission of Type D Meeting Requests to OTP

Type D Meetings may be requested at any stage of development and should be submitted as an amendment under the Pre-IND, IND, or BLA. The meeting request should include a list of the specific objectives of the meeting and a list of questions.

OTP does not send an acknowledgement email or letter following OTP’s receipt of a meeting request. However, by the timelines described in Table 9 , OTP will send the decision to grant or deny the meeting request, along with the meeting date, if granted, or reasons for denial.

Table 9: Timelines for Type D Meetings

OTP Response to Meeting Request**	14 days
Meeting Scheduling or WRO issued***	50 days
Meeting Package Due to OTP	At the time of the meeting request
Meeting Length	60 minutes
OTP Preliminary Response to Questions in the Package to Sponsor	NLT* 5 days before the meeting
Sponsor’s Response to FDA Preliminary Response	NLT 3 days after receipt of Preliminary Responses

*NLT – No Later Than
Source: Table 9 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 OTP 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.

Type D Meeting Package

The meeting package for a Type D Meeting is due at the time of the meeting request.

Number of Questions

The sponsor’s meeting package should include no more than two focused topics, requiring input from no more than three disciplines. The meeting package should not exceed five clearly worded and targeted questions, to allow for a discussion within the duration of the allotted meeting time regardless of meeting format.

Size of Meeting Package

It is important to include background information sufficient to support the questions in the package. OTP may cancel a meeting if the meeting package is grossly inadequate and does not contain sufficient information to enable FDA to address the questions. However, voluminous meeting packages are discouraged. 

Timing of Meeting Package Submission

The meeting package for a Type D Meeting is due at the time of the meeting request as described in the Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products Guidance for Industry and indicated above in Table 9. 

 Examples of Topics Appropriate for a Type D Meeting

Meetings to Discuss:

• Proposed efficacy endpoint for clinical trial
• Clarifying questions regarding proposed statistical analysis plan 
• Potency Assay for CMC
• Analytical comparability strategy for transfer of manufacturing site
• Proposed nonclinical study design to support a change in the clinical route of administration

 Examples of Topics Not Appropriate for a Type D Meeting

• Meeting requested to pre-review CMC, Nonclinical sections of First-In-Human INDs.
• A request to pre-review sponsor’s complete response to IND placed on Clinical Hold
• Although one or two questions are included, they are broad, for example – Are the animal studies presented in the meeting package adequate to support the IND submission? 
   

 Best Practices for Managing Type D Meetings with OTP

Prior to the Sponsor Meeting

• OTP will send the preliminary response according to the timeline indicated above in Table 9. 
• The sponsor is expected to respond to OTP’s preliminary responses according to the timeline indicated above in Table 9 .
• If the sponsor finds that OTP’s preliminary responses and advice are sufficiently clear and complete to obviate the need for further discussion, the sponsor should inform OTP in writing, as soon as possible, so that OTP may cancel the meeting. These responses would then become the official OTP responses to the sponsor’s questions.
  • If, after cancellation of the meeting, the sponsor subsequently wishes to seek clarification from the preliminary responses, then the sponsor may submit a request for clarification. Find out more about Requests for Clarification.
• If the sponsor wishes to continue with the meeting, the sponsor should identify which of the original questions in the briefing package they wish to discuss and list the questions in the proposed order of discussion. As a general rule, the order of discussion is usually the order of importance to the sponsor.  When referencing questions, the sponsor should use OTP’s preliminary responses document numbering format.
• After receiving OTP’s preliminary response, the sponsor should not submit new questions and new information (e.g., alternative approaches or new proposals to address OTP comments) not previously submitted in the original briefing package. OTP preliminary responses are prepared after deliberative review, and usually include cross‑discipline internal discussion, of the original meeting package and questions.  OTP will not have adequate time to review new material and have sufficient inter-discipline internal discussion necessary to prepare answers to new questions.  Therefore, sponsors should thoughtfully prepare their meeting package and questions. 
  • In some situations, a sponsor may want to develop new questions/alternative approaches in response to OTP’s preliminary responses or discussion at the meeting.  Such new questions/alternative approaches should be submitted as an amendment to the sponsor’s existing IND.

During the Meeting

The meeting is the sponsor’s opportunity to obtain clarifications on OTP preliminary responses. As stated above, during the meeting the OTP team will not be able to provide feedback on new information (e.g., new question, alternative approaches, or new proposals to address OTP comments) that was not previously submitted in the original briefing package.

Sponsors may choose to make a presentation at the beginning of the meeting. However, because OTP staff will be familiar with the meeting package content and questions, OTP recommends that sponsors forgo a presentation and use the allotted meeting time to obtain clarifications to OTP’s preliminary responses to the sponsor’s questions.

OTP recommends that time be reserved at the end of the meeting for the sponsor to summarize the major discussion points and action items.

Meeting Summary

OTP will issue the meeting summary within 30 calendar days after the meeting. OTP’s version of the meeting summary is official and the final record of the meeting.  The OTP meeting summary is not a meeting transcript, but focuses on any clarifications (e.g., of unclear preliminary responses), agreements and disagreements, and action items as discussed during the meeting.

The sponsor may submit their version of the meeting summary to the file to summarize their understanding of issues discussed at the meeting. However, OTP may not review such submissions; therefore, the absence of an OTP response to such submissions does not imply OTP concurrence with the sponsor’s version of the meeting summary.

If sponsors disagree with the content of OTP’s meeting summary, OTP’s meeting summary will not be altered except to correct a substantive mistake for the record (on extremely rare occasions).

Requests for Clarification

A request for clarification may be sought after a Type D Meeting, to ensure the requestor’s understanding of OTP's feedback provided in a preliminary response (if the formal meeting was canceled), meeting summary or written response issued by OTP.  

Find out more about Requests for Clarification