Form FDA 2253 is the transmittal form a drug or biologic applicant uses to send FDA its promotional labeling and advertising. Each piece must be submitted at the time of initial dissemination or publication, with the form and a copy of the product's current prescribing information. Since June 24, 2021, these submissions have to be made electronically, in eCTD format.
This article covers who has to file, what the timing rule means in practice, what goes in a submission, the stricter rules for accelerated approval products, how voluntary advisory comments on launch materials work, and the mistakes that cause the most trouble. It summarizes FDA's regulations and guidance as of October 2026. It is not legal advice, and your regulatory team and counsel own the final call for your product.
What is Form FDA 2253, and who has to submit it?
Form FDA 2253, the Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use, is the cover sheet for a postmarketing report. The requirement sits in 21 CFR 314.81(b)(3)(i) for drugs approved under an NDA or ANDA, and in 21 CFR 601.12(f)(4) for biologics licensed under a BLA. Generic manufacturers are covered too.
Submissions go to the Office of Prescription Drug Promotion (OPDP) in CDER, or for CBER-regulated biologics, to CBER's Advertising and Promotional Labeling Branch (APLB). FDA's guidance allows the applicant or an entity acting on its behalf to submit. When another company promotes the product under contract, the application holder should send OPDP or APLB a general correspondence describing the arrangement and note the relationship in later submissions.
What counts as promotional material is broad. FDA's guidance applies the term regardless of format, manner or medium, and its examples include TV and radio ads, brochures, detailing pieces, websites, print ads and exhibits. In practice that brings in rep-triggered emails, banner ads, social posts and video as well.
When is a 2253 due?
For most products, a 2253 is a report, not a request for approval. FDA does not clear the piece before use. The regulation says the applicant submits labeling at the time of its initial dissemination and an advertisement at the time of its initial publication. Not before it is approved internally, and not in a batch at the end of the quarter.
The trigger is first use, not MLR sign-off. A detail aid approved in March and released to the field in June is submitted in June. A piece that is approved and then shelved should not go in at all, and if one was submitted and the company later decides never to use it, FDA's guidance says to send a withdrawal request.
Every meaningful revision is a new dissemination. A revised piece goes in on a new 2253, and in eCTD the guidance says to use the replace operator against the previously submitted files. Websites follow their own rule: the whole site goes in at first use, an updated page or section can go in alone with a cross-reference to the original submission date, and a substantially revised site goes in again in full.
What goes in a 2253 submission, and does it have to be eCTD?
Three things are required: a completed Form FDA 2253 on the most current version of the fillable form, the promotional material itself, and the product's current labeling. For OPDP, the form accompanies final materials only. Annotated versions cross-referenced to the labeling and references are encouraged but not required for a 2253.
FDA's guidance adds a set of filing rules. Use the most specific material type code on the form rather than a generic one. Submit professional and consumer materials separately. Do not include a cover letter, correspondence or Form FDA 356h. When a piece mentions several products, list the lead application number and attach the others. When different OPDP reviewers cover different indications, submit single-indication pieces separately where you can.
eCTD is mandatory for 2253 submissions and for accelerated approval presubmissions. FDA finalized the electronic format guidance on June 24, 2019 under section 745A(a) of the FD&C Act, and paper stopped being accepted for these submission types 24 months later. The current version is Revision 1, from April 2022. Materials sit in module 1, section 1.15, and the current labeling goes in section 1.14.6. FDA's OPDP eCTD page offers test submission checklists, which are worth using before the first live sequence.
The submission should also show the piece the way its audience sees it. For interactive pieces, websites and e-detail aids, FDA notes that static screenshots may not convey the message, and a video of someone navigating the piece can accompany the submission.
How do accelerated approval presubmissions work after FDORA?
Products approved under accelerated approval carry a stricter rule. Section 506(c) of the FD&C Act lets FDA condition approval on the sponsor submitting copies of all promotional materials during the preapproval review period and, after approval, at least 30 days before dissemination, for as long as FDA decides. FDA implements this in 21 CFR 314.550 and 601.45.
In practice there are two windows. Materials the company plans to use in the first 120 days after approval go to FDA during the preapproval review. After that, unless FDA says otherwise, each new piece goes in at least 30 days before its intended first use. A presubmission includes correspondence, a clean and an annotated version of each piece, the current PI annotated to the piece, and annotated references. For OPDP these drafts are not filed on Form FDA 2253. If the company decides to use a piece before FDA comments, it notifies FDA in a general correspondence, and if it decides not to use it, it files a withdrawal request.
The Food and Drug Omnibus Reform Act of 2022 (FDORA) reorganized section 506(c). The promotional materials condition now sits at 506(c)(2)(A)(ii), and the 30-day rule itself did not change. FDORA also set out expedited procedures for withdrawing an accelerated approval, and dissemination of false or misleading promotional materials is one of the four grounds listed. FDA described how it intends to use those procedures in a December 2024 draft guidance. For a team launching under accelerated approval, the practical effect is that the launch calendar has to be planned backward from FDA's review windows, and promotional discipline is tied to the approval itself.
Should you ask OPDP for advisory comments on launch materials?
Advisory comments are voluntary, under 21 CFR 202.1(j)(4), and FDA encourages them before launch. The launch phase is the first 120 days that a new product, indication, formulation, dosage form, dosing regimen, strength or route of administration is marketed. FDA treats core launch materials as a high priority: one comprehensive professional piece of 12 pages or fewer, one professional ad of 4 pages or fewer, the consumer equivalents of each, and a product website or e-detail aid derived from a comprehensive piece.
Other launch materials, such as slide kits or longer pieces, are lower priority, and FDA recommends applying its comments on the core materials to them. An advisory request is not a 2253 and should never be bundled with one. If FDA learns that the material, or substantially similar claims, has already been disseminated, it will generally not review it. Once the reviewed pieces go live, they still go in on Form FDA 2253 at first use.
What are the most common Form FDA 2253 mistakes?
Filing errors come first: the wrong application number, a vague material type code, professional and consumer pieces in one submission, a 2253 combined with an advisory request, an outdated version of the form, or missing current labeling. FDA's training on grouped submissions, where one piece references several applications, flags errors such as choosing the single product option on a grouped submission.
Timing errors are more serious. Submitting at MLR approval puts pieces on record that never ran, and submitting late leaves pieces in market that FDA has not received. Missing a revision is the most common version of the second problem: an updated email template, a refreshed web section or a reprinted leave-behind that never got its own submission. An asset that never reached the agency can become a finding of its own, as the letters OPDP sends show.
The root cause is usually that the 2253 log and what is actually live drift apart. Pieces expire in the review system but stay on a website, an agency reuses an old banner, a template is edited in the CRM. The fix is one inventory keyed by piece ID that records approval date, first-use date, 2253 submission date and sequence number, channel, status and expiry, reconciled against what is live on a fixed schedule and every time the prescribing information changes. A label change is the hardest test of that inventory, and we cover it in what to do with live materials when the label changes.
Where SwishX fits
A 2253 is only as reliable as the record behind it: which claim, which reference, which version of the label. Magic Studio builds that record as the asset is made. Every claim is cited to its source and checked against the label for its market, fair balance and safety information are placed in the asset as it is made, and finished work goes into the MLR queue and on into Veeva PromoMats with every claim and its reference attached.
SwishX does not file submissions and is not a replacement for PromoMats or your regulatory publishing tools. It sits upstream, so the pieces that reach your reviewers, and later your 2253 log, trace back to one Brand Dossier. See how that works in Magic Studio.
Frequently asked questions
What is Form FDA 2253 used for?
Form FDA 2253 is the transmittal form that accompanies promotional labeling and advertising submitted to FDA for an approved prescription drug or biologic. It fulfills the postmarketing reporting requirement in 21 CFR 314.81(b)(3)(i) and 21 CFR 601.12(f)(4).
When must Form FDA 2253 be submitted?
At the time of initial dissemination for promotional labeling and at the time of initial publication for an advertisement. The trigger is first use in the market, not internal MLR approval.
Is eCTD required for Form FDA 2253 submissions?
Yes. Under section 745A(a) of the FD&C Act and FDA's 2019 guidance, 2253 submissions and accelerated approval presubmissions have had to be made electronically in eCTD format since June 24, 2021, and paper copies are no longer accepted for them.
Does FDA approve materials submitted on Form 2253?
No. For most products a 2253 is a report, not a request for approval, although FDA may review the material and can respond with an untitled or warning letter. Review before use applies to accelerated approval products and other cases where FDA requires it, or when a company asks for advisory comments voluntarily.
Do I need a new 2253 when a promotional piece is revised?
Yes. A revised piece is a new dissemination and goes in on a new Form FDA 2253 when it is first used, with the current labeling. In eCTD, FDA's guidance says to use the replace operator against the previously submitted files.