FDA Form 2253
The transmittal form a manufacturer files with the FDA when a promotional piece is first used.
FDA Form 2253 is the transmittal form a pharmaceutical manufacturer submits to the FDA's Office of Prescription Drug Promotion (OPDP) when a new promotional piece, an ad, a journal insert, a leave-behind, an HCP-facing leaflet, is first used. The form itself is short. What matters is the timing: it's expected within 10 days of first use, with a copy of the actual material attached, which is how OPDP builds its record of what's circulating in the market.
It's the step that comes right after internal sign-off, not before. A piece clears its Promotional Review Committee first. Form 2253 is what formally puts it on OPDP's radar once it's actually out in the world. If OPDP later flags the piece as misleading or unsubstantiated, the warning or untitled letter that follows references the 2253 filing directly.