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How should Form FDA 2253 be prepared?
Establish the receiving office, submission purpose and whether the material is draft or final, then reconcile the transmittal with the actual promotional pieces and applicable labeling. OPDP and APLB handling differs. A technical receipt does not establish FDA approval of the claims or turn a disseminated piece into an unused draft.
Before you begin
Promotional-material transmittal for applicable human prescription-drug and biologic workflows. OPDP and APLB draft handling differs. This form neither grants promotional approval nor authorizes investigational-drug promotion.
What you will prepare: A reconciled transmittal and material inventory matching the actual promotional submission.
Establish office and material state first
For OPDP, distinguish final reporting from a request for comments on an unused draft; do not attach a 2253 to an OPDP draft advisory request merely because it concerns promotion. APLB has different form handling, including the CBER-only draft/final selection. Establish the actual receiving office and purpose before completing the transmittal. The CDER IND option on the inspected form concerns an authorized CDER EUA associated with an IND; it is not a general route for advertising an investigational drug.
Reconcile the transmittal with the actual pieces
Build an inventory of the application and product names, applicable current package insert, material identifier/title, intended audience and each submitted piece. Match the completed form to that inventory and the actual files. Treat a kit’s components as identifiable materials rather than hiding them under an uninformative bundle name. Preserve real dissemination information and the responsible official’s contact and execution details. When a material identifier is duplicated, resolve which artifact it identifies before finalizing the form.
Check the companion artifacts
For final reporting, reconcile the actual disseminated material with the applicable current labeling and the submission timing rule. Keep clean pieces distinguishable from annotated review copies; annotations do not replace the complete final piece. Use the promotional evidence-package guide and the labeling record at 1.14.6 for the companion workflow. Technical receipt of the submission does not establish that FDA approved its claims.
Fictional example: the form identifies the wrong version
The transmittal lists a brochure identifier that belongs to an earlier campaign, while the PDF contains revised claims. Retrieve the released material record, establish the correct identity and reconcile every occurrence in the form and files. If the piece has already been disseminated, do not relabel it as an unused draft to obtain advisory review. Have the regulatory owner resolve the actual reporting or correction route.
Tie each transmittal entry to the exact promotional artifact
Use a piece-level map before the responsible official reviews the form.
| Attribute | Record | Discrepancy to resolve |
|---|---|---|
| Office and purpose | OPDP or APLB and actual submission task | Draft and final processes are being combined |
| Material identity | Released identifier, title and version | A campaign name hides several different pieces |
| Material state | Draft status or actual dissemination record | A used piece is labeled unused |
| Submitted file | Complete piece and any separate annotations | Marked-up extracts replace the final artifact |
| Labeling context | Applicable current labeling and product identity | Claims refer to a different version or presentation |
Version exercise: a kit contains a revised brochure and an unchanged insert, but both use one inherited material identifier. Recover the actual released identities and reconcile the form and companion inventory. Do not solve an ambiguity by assigning an unverified new identifier to an already disseminated piece.
The official form inspected for this update has a 02/26 footer; the separate instructions have an 11/21 footer. Check the field labels, including the CBER-specific selection, against the actual receiving-office workflow.
Use the promotional evidence-package guide for the complete companion package. The form is useful only when its entries identify the artifacts and purpose the reviewer will actually receive.
Your preparation checklist
0/3 checkedUse this to track your review in this visit. Checks are not saved and do not establish regulatory compliance.
Frequently asked questions
Should Form 2253 accompany an OPDP request for comments on unused draft material?
FDA’s promotional-submission guidance distinguishes OPDP draft advisory requests from final promotional reporting and does not direct use of Form 2253 for that OPDP draft request. Resolve the actual office and purpose first; CBER/APLB form handling is different.
Does the CDER IND option authorize general investigational-drug advertising?
No. The inspected instructions identify that option in connection with an authorized CDER EUA product associated with an IND. It is not a general permission to promote an investigational drug. Establish the actual product status and applicable submission context.
Does a submission receipt mean FDA approved the promotional claims?
No. Receipt concerns delivery of the submission, not a substantive approval of its claims. Preserve the actual material status, applicable labeling and responsible review, and distinguish reporting from any separate advisory process or agency response.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
Form instructions
Form FDA 2253: Transmittal of Advertisements and Promotional Labeling ↗Actual XFA form 02/26, printed OMB expiry July 31, 2027. Fields and CBER-only draft/final selection inspected September 22, 2026.
Form instructions
FDA: Instructions for Form 2253 ↗11/21 instructions; item 2 distinguishes the CDER IND option for authorized EUA products. Checked September 22, 2026.
Guidance
FDA: Submissions of Promotional Labeling and Advertising Materials ↗April 2022 final Revision 1; IV.A and IV.C, VI–VII. OPDP/APLB distinctions; checked September 22, 2026. Legacy XML syntax is not v4 publishing instruction.
Technical specification · placement only
FDA eCTD v4.0 comprehensive hierarchy ↗Version 2.2, February 2025. Section 1.1. A heading identifies placement, not mandatory applicability.