Pre-BLA meeting

Purpose of Meeting. The purpose of the pre-NDA or pre-BLA meeting is to discuss filing and format issues. The CMC portion of the pre-NDA or pre-BLA meeting is a critical interaction between the CMC review team and the sponsor to ensure the submission of a well-organized and complete NDA or BLA. 

Focus of Meeting. The pre-NDA or pre-BLA meeting should focus on addressing the specific questions related to filing and format issues. Typically, the meeting also includes a discussion to identify problems that can cause a refuse-to-file recommendation or hinder the review process. Examples of CMC issues that could be addressed in pre-NDA or pre-BLA meetings include, but are not limited to... 

Pre-NDA, pre-PMA, pre-BLA—held to determine the requirements for producing a high-quality marketing application that will be accepted for filing. The meeting provides reviewers an overview of the data that will be presented in the marketing application. 

The following sections provide specific guidance and more detailed information on each of the three basic types of meetings—pre-IND, EOP2, and pre-NDA or pre-BLA—as well as examples of the CMC issues typically addressed in each of these meetings. 

Senior-level staff need to understand how the communication process works with the FDA, for example, End-of-Phase II Meetings, IND Annual Report, FDA Advisory Committee meetings, Pre-New Drug or Biologic Licence Applications (NDA/BLA) Meetings, clinical holds, IND termination, and FDA audits. 

Type B meetings are those that usually occur for a pre-IND, an End of Phase 1 (EOP1), an End of Phase 2 (EOP2), a Pre Phase 3, or a Pre-NDA or BLA. All of these meetings will be honored by the FDA. These meetings are usually scheduled 60 days from the time the agency received the written request. If the sponsor requests a date beyond 60 days, the meeting should occur no later than 14 days after the date requested. 

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