The pre-New Drug Application (NDA)/pre-Biologics License Application (BLA) meeting is a critical meeting between the sponsor and FDA to ensure the submission of a well-organized and readily reviewable NDA/BLA. This includes a discussion of the format and content of the anticipated application, and the presentation of data, the dataset structure, the acceptability of data for submission, and the projected submission date of the application. The meeting should be held in advance of the planned marketing application submission to allow for a meaningful response to FDA feedback and should generally occur no less than 60 days prior to the planned submission.
Potential topics for questions at the pre-NDA/pre-BLA phase of development include questions surrounding formatting of the submission, such as regulatory requirements, organization of the submission, the electronic common technical document (eCTD), and questions related to evidence of effectiveness seen in the Phase 3 study. The pre-NDA/pre-BLA meeting helps to determine whether outstanding issues require additional data or studies/trials that may affect the ability to file the future submission.
Examples of pre-NDA/pre-BLA meeting topics include: unresolved issues, trials to support quality, safety and efficacy, pediatric studies, data summary, data format and presentation, drug name review, new molecular entities (NMEs), preliminary discussions of risk management plans, post-marketing studies or trials, quality information and inspection considerations, outline of data to be submitted for abuse potential assessment and drug scheduling.