FDA Meetings & Communication

Pre-meeting materials that provide background, key data, and specific questions to support efficient regulator feedback and clear meeting outcomes.

An FDA meeting pathway (commonly for CBER) to facilitate early communication on innovative products, often before a traditional pre-IND meeting.

A written record of a regulatory meeting that captures discussion, agreements, decisions, and action items used to align teams and demonstrate follow-through.

An FDA formal meeting category intended to address urgent, program-stalling issues (e.g., clinical hold, dispute resolution, post-action).