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OTP Pre-BLA Meetings

Pre-BLA (Type B) meetings for Original Submissions and Efficacy Supplements

The primary purpose of a pre-BLA meeting is to discuss the planned content of the marketing application. This meeting is an opportunity to:

  • identify any major unresolved issues from the development program,
  • familiarize the review team with the studies the applicant is planning to rely on to provide evidence of the product’s effectiveness,
  • identify the status of ongoing or needed studies adequate to assess pediatric safety and effectiveness,
  • acquaint FDA reviewers with the general information to be submitted in the marketing application,
  • discuss appropriate methods for statistical analysis of the data, and
  • discuss the best approach to the presentation and formatting of data in the marketing application.
  • discuss CMC readiness for a BLA, e.g., commercial manufacturing process, and product comparability (if applicable)

Submission of Pre-BLA (Type B) meeting requests to OTP

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 OTPRPMS@fda.hhs.gov regarding submission of the meeting request to the file is greatly appreciated.

OTP does not send an acknowledgement email or letter following OTP’s receipt of a meeting request. However, by the timelines described in Table 3, OTP will send the decision to grant or deny the meeting request, along with the meeting date, if granted, or reasons for denial.

Table 3: Timelines for Pre-BLA (Type B) Meetings

OTP Response to Meeting Request**

21 days

Meeting Scheduling ***

60 days

Meeting package due to OTP

At least 30 days before the scheduled date of the meeting

Meeting Length

90 minutes for original BLA submissions, 60 minutes for Efficacy supplemental BLA

OTP Preliminary Response to questions in the package to Sponsor

NLT* 2 days before the meeting

Sponsor’s Response to FDA preliminary response

NLT than 24 hours before the meeting

*NLT – No Later Than
Source: Table 3 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.

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