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How do you keep clean promotional material and its evidence package consistent?
Use one controlled material identity and compare the actual presentation across the clean piece, annotated piece, labeling and references. Map each claim to precise support and preserve the source context. Represent interactive paths, audio/video and physical use so the reviewer can understand the intended experience. Match the artifact set to draft review or final reporting, since annotations are not universally mandatory for final 2253 submissions.
Before you begin
Human prescription-drug promotion within the FDA April 2022 guidance. Artifact expectations vary between draft advisory/presubmission and final 2253 reporting; annotations are not universally mandatory.
What you will prepare: An identifiable promotional piece with coherent companion artifacts and a tested evidence trail.
Give each artifact one clear role
| Electronic heading | Artifact | Preparation task |
|---|---|---|
| 1.15.2.1.1 | Clean material | Show the actual intended presentation without reviewer annotations |
| 1.15.2.1.2 | Annotated material | Connect claims and presentations to pinpoint support |
| 1.15.2.1.3 | Annotated product labeling | Preserve the label and mark the passages used in the piece |
| 1.15.2.1.4 | Annotated references | Provide identifiable supporting sources with relevant passages and links |
Sections VI.F–H distinguish draft review packages from final 2253 reporting, where annotations may be optional. Select the package from the actual purpose. A clean final material is not the same thing as an annotated draft with the comments hidden.
Preserve identity across variants
Use one material identity with clear versions and artifact roles. Compare clean and annotated copies page by page. Record audience, medium, language and intended use. For interactive material, document the user paths and conditional content; a screenshot of the first screen may omit the actual claim or risk presentation. Keep the publishing metadata consistent with the manifest, using the supported format’s controlled values rather than copying legacy XML attributes into a v4 package.
Annotate evidence without changing its meaning
Mark the specific label passage or full reference location used by each claim. Retain the study context and limitations. Verify links after final pagination and conversion. For current product labeling accompanying 2253, retain the separate 1.14.6 role even when an annotated label is also supplied. A reference attached to a claim is not itself a regulatory or scientific judgment that the presentation is appropriate.
Fictional example: hidden version drift
The clean brochure says “reduced events,” while the annotated copy still says “reduced risk.” Reconcile the actual intended wording and send the changed claim for review; do not count matching filenames as version control. If the piece becomes a video, review the timed presentation and the complete media file as well as the static annotation map.
Review both claim support and the complete presentation
A claim spreadsheet can be internally correct while the actual piece communicates something broader. Review the rendered presentation and the evidence relationship together, keeping the annotation layer from obscuring the material the audience will see.
| Review dimension | Working record | Question |
|---|---|---|
| Exact claim | Words, numbers, image or implied comparison and location | Is the clean piece identical in substance to the annotated piece? |
| Evidence | Versioned label or full reference with pinpoint locator | Does it support the actual population, endpoint and strength of statement? |
| Risk and limitation context | Relevant accompanying information and placement | Does the presentation omit or obscure context needed to understand the claim? |
| User experience | Medium, dimensions, sequence and description of use | Can the reviewer reconstruct what the audience encounters? |
| Variant | Language, audience, responsive state or audiovisual version | Was each materially different presentation assessed? |
| Release artifact | Actual final file or captured rendition and review disposition | Does it still match the supported version after conversion or production? |
For interactive material, record the available selections and resulting screens, including conditional content. Guidance VII explains that when a fully functional piece cannot be submitted in an approved format, the package must allow all interactive selection options to be viewed as still images with notes explaining functionality. A screenshot of the homepage does not represent a calculator result, expanded risk section or a branch revealed after user input.
For physical material, show the actual size, folds, panels and intended combinations. A booth panel whose meaning depends on adjacent panels needs a clear description of use. For audiovisual pieces, reconcile the timed presentation as well as the script. Use the TV review guide for the applicable major-statement checks.
Fictional interactive review: a starting screen presents a qualified statement, but selecting an option reveals an unqualified benefit claim in a results panel. The package includes only the starting screen and the reference supporting its qualified text. Add the omitted state and assess the claim actually shown there; do not label the whole tool supported because the first screen passed review.
Guidance VI.I describes each draft promotional material with its own clean and annotated versions, annotated labeling and applicable references when multiple materials are submitted for review. Keep those relationships understandable even where the underlying sources are shared. For final postmarketing reporting, clean final materials remain necessary; optional annotations do not replace them. Guidance VII.A also distinguishes a representation of the actual disseminated piece from a proof or galley alone for OPDP 2253 reporting.
Finally, test from the package the reviewer will receive. Open the clean material, compare its substance with the annotated version, follow each source relationship and inspect the actual rendition. Keep current labeling for 2253 separately identifiable. Resolve missing support or missing material according to what was actually absent.
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
Can a proof or galley alone represent the final material in an OPDP 2253 submission?
Guidance VII.A calls for a representation of the actual piece disseminated, rather than solely a proof or galley. A proof may also help explain layout or size. Establish the actual final rendition and its relationship to the review record instead of assuming the last design proof is identical.
Is a homepage screenshot enough for an interactive promotional tool?
Not when it omits the presentation available through other selections. Where a functional piece cannot be supplied in an approved format, the guidance describes still images covering all interactive options with explanatory notes. Represent conditional results, expanded content and navigation so the reviewer can understand the complete intended experience.
Can several draft pieces share one unlabeled pile of annotated references?
Keep each piece’s claim-to-source relationship identifiable. Guidance VI.I describes the companion artifacts for each draft material in a multiple-material submission. Sources can be common, but the reviewer still needs to know which exact passage supports each presentation, with the correct versions and usable navigation.
Are matching material IDs enough to establish clean and annotated version consistency?
No. Compare the actual wording, numbers, images, tables and presentation. The same identifier can be attached to different versions, and annotation files can lag behind revisions. Resolve substantive differences and recheck the packaged links after conversion; matching metadata alone does not establish a coherent evidence package.
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 1.15.2. A heading identifies placement, not mandatory applicability.