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How do you prepare a voluntary promotional advisory-comment request?
Verify that the proposed material and substantially similar claims or presentations have not already been disseminated, identify launch status and audience, and ask specific questions about the actual draft. Supply matching clean and annotated material with current labeling and relevant support. Keep OPDP and APLB form handling distinct. FDA comments are advisory input, not a universal approval of the campaign.
Before you begin
Voluntary advisory comments on human prescription-drug promotion. Launch versus non-launch and OPDP versus APLB affect preparation; the process is not mandatory presubmission or approval of the advertisement.
What you will prepare: A request identifying the review question and a coherent draft-material evidence package.
Sections covered in this guide (2)
Establish whether the material is still a draft for first use
Check actual dissemination/publication, including substantially similar claims or presentations. FDA’s IV.C describes a process intended to provide input before use. Determine launch status using the guidance’s context, not the date your designer began work. Separate professional and consumer audiences. For a TV proposal, use the dedicated TV preparation task rather than burying it among unrelated materials.
Write a focused request
Use an editorial outline: product/application and contact; voluntary advisory purpose; launch/non-launch and audience; material list and intended use; specific questions; previous agency comments/tracking reference; attachments. Explain whether a launch piece is core or non-core under the guidance instead of promising priority. For OPDP draft advisory submissions, do not automatically attach Form 2253; the guidance describes different APLB form handling. Verify the current form instructions if a form applies.
Make the review evidence navigable
Supply the clean draft, matching annotated draft and applicable annotated current labeling and references. Map claims to pinpoint support. Preserve limitations in the cited study rather than highlighting only a favorable sentence. Check that the annotation layer points to the same wording the reviewer sees in the clean material. Questions should concern actual uncertainties; “please approve everything” is not an actionable request.
Fictional example: a reused claim changes eligibility
A non-launch brochure is new, but its headline and presentation already appeared online. Disclose that use and resolve the appropriate review route with the regulatory owner. Do not assert that a new layout makes the claims unused. If a launch request contains no specific review question, ask the content owner to identify the disputed presentation and prepare the supporting evidence before filing.
Make each advisory question answerable from the package
Start with the presentation the reviewer will see, then identify the specific uncertainty. A request to “approve all claims” gives neither a focused issue nor the evidence needed to assess it. Use a working question record before composing the letter.
| Field | Record | Review test |
|---|---|---|
| Material and location | ID, version, page or screen and exact presentation | Is the question attached to the same draft as the clean file? |
| Proposed interpretation | What the audience is intended to understand | Does wording, imagery or juxtaposition imply more than the sentence alone? |
| Support | Current label passage and applicable full reference with locator | Does the support concern the actual product, population and endpoint? |
| Uncertainty | The narrow issue on which comments are requested | Can a reviewer answer without guessing the sponsor's intended message? |
| Prior agency input | Comment date, tracking reference and relevant disposition | Is a previously raised issue being presented as new? |
| Use and launch status | Actual campaign history and intended first use | Were substantially similar claims already used elsewhere? |
For voluntary advisory review, the guidance defines launch by the first 120 days the approved product, indication or listed product change is marketed to the public. Do not substitute the date a design project began. The accelerated-approval presubmission framework uses its own approval-related timing; similarly named launch categories do not make the two processes interchangeable.
Core launch status is a review-priority category with content and length boundaries, not a guaranteed service level. The guidance generally describes one comprehensive professional piece of 12 or fewer pages, one professional advertisement of 4 or fewer pages excluding PI or brief summary, and corresponding consumer pieces within the stated limits. It also describes qualifying derivative websites or electronic sales aids. Assess the actual category; do not split an oversized piece into artificial files and call it core merely to fit a limit.
Fictional question exercise: a draft headline uses a trial result beside an image that suggests benefit in a broader population. The annotation accurately cites the trial, but the question asks only whether the number is correct. Revise the request to identify the proposed audience interpretation, population limitation and actual presentation. The citation can support the number while leaving the implied breadth unresolved.
FDA generally will not review material through this voluntary process if it learns the material or substantially similar claims or presentations have been disseminated, including after submission. Maintain the use-status check while review is pending. If the business changes its intended use, assess the appropriate withdrawal communication. Keep TV proposals separate from unrelated material and use the evidence-package guide to reconcile annotations.
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
Does a new layout make previously used claims eligible for voluntary advisory review?
Not by itself. The guidance considers both the material and substantially similar claims or presentations. Check actual dissemination across channels, disclose the history and resolve the appropriate route. A different file name, layout or campaign identifier does not establish that the relevant presentation is unused.
Does core launch status guarantee FDA comments by a fixed date?
The guidance describes core launch review as a high priority and sets content and page boundaries; it does not make that classification a universal guaranteed turnaround. Establish the actual category and current interactions, and do not promise a release date based only on a core label in the manifest.
Should an OPDP draft advisory request use Form FDA 2253?
The April 2022 guidance says not to use Form FDA 2253 for draft promotional materials voluntarily submitted to OPDP. It describes different draft-form handling for APLB. Resolve the responsible office and current instructions; do not import final-reporting form choices into every draft-review request.
What happens if the piece is disseminated while advisory review is pending?
The guidance says FDA generally will not review under the voluntary process if it learns the material or substantially similar claims or presentations have been disseminated, including after submission. Record the actual use and assess the relevant notification or withdrawal and separate final-reporting obligations.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
Guidance
FDA: Submissions of Promotional Labeling and Advertising ↗April 2022 final, Revision 1; IV.A–J, VI.E–H and VII. PDF production/PRA update April 2023 does not change the cover revision. Its legacy backbone syntax is not an eCTD v4 implementation guide. Checked September 22, 2026.
Technical specification · placement only
FDA eCTD v4.0 comprehensive hierarchy ↗Version 2.2, February 2025. Section 1.15.1.1. A heading identifies placement, not mandatory applicability.