Pre-submission meetings with the FDA — including pre-IND, End-of-Phase-2 and pre-NDA/BLA meetings — are among the most valuable interactions a sponsor can have with the agency. Used well, they can clarify the regulatory path, resolve disagreements about data requirements, and reduce the risk of unexpected requests at the application stage.
But the quality of a pre-submission meeting depends almost entirely on the quality of the briefing package submitted beforehand.
What the FDA expects
The FDA reviews your briefing package before the meeting and forms preliminary responses. Arriving with a poorly organised package means the agency cannot prepare useful answers, and meeting time is wasted.
A strong briefing package typically includes a clear product description and development stage, a concise summary of relevant data, specific answerable questions — usually no more than five to ten — and your proposed answer or position for each question where you have one.
Writing good questions
The single most important element is question quality. Good pre-submission questions are specific, data-supported, and decision-relevant — focused on questions where the FDA's answer will actually change what you do next.
Timing
For pre-IND meetings, submit the briefing package at least 30 days before the requested meeting date. For pre-NDA/BLA meetings, 90 days is more realistic given the volume of data involved. Build this lead time into your development timeline.
How TPC can help
We assist sponsors at every stage of FDA meeting preparation — from identifying the right meeting type, to drafting and refining questions, to preparing the full briefing package and supporting the meeting itself. Contact us to discuss your upcoming interaction with the FDA.