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OTAT IND Milestone (Type B) Meetings

End of Phase (EOP) meetings (e.g., EOP1, EOP2)

The purpose of an End of Phase 1 meeting is to discuss further product development plans.

The purpose of an End of Phase 2 meeting is to determine the safety of proceeding to Phase 3, and to evaluate:

  • the Phase 3 plan and protocols
  • the adequacy of current studies
  • plans to assess pediatric safety and effectiveness
  • identify any additional information necessary to support a marketing application for
  • the product and indications under investigation
  • CMC readiness for Phase 3 (e.g., adequate critical quality attributes (CQAs) and qualified potency assay).

Submission of End of Phase (Type B) 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 End of Phase (Type B) Meetings

OTAT Response to Meeting Request**

14 days

Meeting Scheduling or WRO issued***

70 days

Meeting package due to OTAT

At least 50 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 teleconferences or face-to-face meetings)

NLT* 5 days before the meeting

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

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.
**** If the scheduled date of a Type B (EOP) meeting is earlier than 70 days after FDA receipt of the meeting request, then the requester’s meeting package will be due no sooner than 6 calendar days after the date of the FDA letter granting the meeting.

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