FDA Form 2253

Updated 2026-07-13 · markdown version

FDA Form 2253 ("Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use") is the form under which US prescription-drug promotional materials are submitted to FDA at time of first use. Each promotional piece — sales aid, website, e-detail, TV spot — is filed with the agency's Office of Prescription Drug Promotion (OPDP) along with the material itself and its references.

Two properties shape the workflow around it. First, 2253 submission is notification at use, not pre-approval — FDA generally sees material as it launches (pre-clearance applies mainly to specific cases such as certain accelerated-approval products). Enforcement is post-hoc, via OPDP untitled and warning letters. Second, the filing must be complete and internally consistent — final approved material, annotated references, current labeling — which makes the 2253 package the downstream artifact of a clean MLR review: everything the committee verified is what gets filed.

The UK has no direct analog: material is gated instead by pre-use certification under the ABPI Code, with complaint-driven enforcement through the PMCPA. Teams operating in both markets file 2253s in the US and rely on the signatory gate in the UK.