A screenshot checklist for pharma website MLR submission

This is the list to run down before a website capture set goes into MLR routing. It is in the order the work happens: what to decide before capturing, what to capture on every page, what reviewers will check on the captures, how to assemble the package, and what record to keep. Each item says why it is there. The regulatory items are drawn from the FDA’s promotional-material rules and submission guidance, cited at the end; the practical ones come from the earlier guides on the ISI, cookie consent and the PromoMats package.

It is written by RouteShot, which produces most of this automatically; the last section says which items it covers and which it does not. It is not regulatory advice. Your client’s regulatory team owns the final word on every item.

1. Before you capture

• Scope is the whole site. Every URL in the sitemap plus any page reachable by navigation that the sitemap misses. The sponsor must submit the entire product website at first use, so a page left out of review is a page that reaches the FDA unreviewed.
• Professional and consumer sections are separate sets. Websites with distinct sections for health care professionals and consumers are submitted as two submissions. Capture them as two sets from the start, with the HCP gate captured in the HCP set.
• One indication per set where the site allows it. The FDA asks firms to submit materials that promote one indication separately when possible. On a multi-indication site, a set per indication, each starting from that indication’s own landing page.
• Environment is fixed and named. Staging URL, credentials, and a note of whether it matches what will go live. Never capture a moving target.
• Widths are the organisation’s standard, not today’s window. Desktop and mobile, the same widths as the last milestone, so two sets are comparable.
• Consent path is decided. Reject-all, accept-all, or no answer, recorded before the run, applied to every page.
• ISI handling is on for any page with a sticky safety tray, and the tray is identified.
• Interactive states are listed. Accordions, tabs, carousels, modals, navigation menus, forms. The FDA’s position is that static images may not adequately convey how interactive materials convey their messages, so the set has to show them.

2. On every page

• Above-the-fold at each width, with the ISI tray visible as a visitor sees it.
• Full-page at each width, with the tray hidden and the in-flow ISI complete at the bottom, no floating band anywhere.
• ISI expanded state, and the collapsed state if the tray loads open, as their own captures.
• Accordions and tabs open, carousels stepped, modals and inline panels shown, navigation menus open.
• Forms in their empty state and their validation-error state, never submitted. Thank-you pages only when their URL is supplied.
• Video posters rendered, and a video file or a screen recording of anything that moves, because the reviewer must be able to experience the site as a user or receive images of each page together with the videos.
• On the landing page only: the consent banner as it first appears and its settings panel, before dismissal.
• Every file named with page, width and state, so the set is self-describing whatever the routing tool calls its fields.

3. What reviewers will check on the captures

These are content checks, not capture checks, but the capture has to make them possible. If a reviewer cannot answer one of these from the set, the set comes back.

• The established name travels with the brand name. In prescription drug advertising the established name must be printed in letters at least half as large as the proprietary name. Reviewers look for it in the header, the hero and the footer at both widths, so the mobile captures matter as much as desktop.
• Fair balance. An advertisement is misleading if it fails to present a fair balance between information relating to side effects and contraindications and information relating to effectiveness. That is what the ISI captures, the above-the-fold shot and the full page are for: is risk information present, with comparable prominence, on arrival and throughout.
• The brief summary, or the route to it. Advertisements must present a true statement of information in brief summary relating to side effects, contraindications and effectiveness. On a website that is typically the full ISI in flow and a link to the full prescribing information, and the reviewer checks both are reachable on every page.
• Claims match the labeling. Each claim on the page is traceable to the PI or a reference. This is what the annotated copy exists for, and it is why page order and page identity need to be stable between versions.
• Consent and privacy elements are present and correct: the banner, the settings defaults, the withdraw affordance, and the California opt-out link where the site needs one.
• Nothing is hidden by the capture. No band mid-page, no banner over the fold, no clamped tall page, no blank lazy-loaded image.

4. Assembling the package

• A compiled PDF, one capture per page, in navigation order. That is what the routing tool renders and what the eventual submission needs; script-dependent HTML is not an acceptable submission format, PDF is.
• Page order kept between versions. Annotations brought forward in the routing tool land by position. Reorder the pages and every annotation is on the wrong page.
• A cover page with site, environment, capture date, widths, consent path, ISI setting and page count.
• A manifest listing every page and every state captured, with any page that failed and whether it was retried.
• The clean set kept clean. The clean version carries no annotations to the label or references. Annotations live on a separate copy or in the routing tool.
• An annotated copy identifying the source of support for each claim, by page and line of the PI or page and paragraph of the reference. Encouraged for postmarketing submissions, required for advisory-comment and accelerated-approval submissions.
• The current PI as a PDF alongside, and the patient labeling or Medication Guide where applicable, with references as individual PDFs.

5. The record

• Who ran the capture, when, against which URLs, with a per-page outcome. This is the answer to the first question a reviewer or auditor asks, and it is what makes a later update submission possible: an updated page or section is submitted with a cross-reference to the original submission and its date, and a substantially revised site is submitted again in full.
• Which version of the site. A build number, a deploy date, or at least the staging URL and time.
• What changed since the last set, so the update path can be chosen deliberately rather than by recapturing everything.

6. The usual send-backs

• An ISI band stamped down the full-page capture.
• A page missing because the sitemap missed it.
• Desktop captured at one width this milestone and another last milestone.
• The cookie banner in the above-the-fold shot, or missing entirely.
• Page order changed, annotations orphaned.
• A stale PI in the package.
• No date on anything.

Each of these costs a full re-run at the point in the cycle when there is least time for one.

7. What RouteShot covers

Covered. Scope from the sitemap or a URL list, with path and locale filters. Sections for multi-indication sites, each with its own landing page. Standardised widths set once per organisation. The consent path as a project setting, the banner and settings captured before dismissal. ISI handling with the tray hidden in full-page captures and the expanded and collapsed states as artifacts. Accordions, tabs, carousels, modals, menus and form states captured and verified. Video posters rendered. Self-describing filenames, navigation order, per-page retry, and a job record with actor, time, URL set and outcome. Output as an organised ZIP today and a compiled review PDF with cover page next.

Not covered. The annotated copy, the PI and reference PDFs, the claims-to-labeling check, the tag audit behind the consent banner, and the submission itself. Those are the regulatory team’s work, and the capture set is built to make them faster rather than to replace them.

If the list above is your milestone routine, request access and we will run a live site of yours through it so you can compare the set with what you produce today.

Sources

• FDA, Providing Regulatory Submissions in Electronic and Non-Electronic Format: Promotional Labeling and Advertising Materials for Human Prescription Drugs, Guidance for Industry, April 2022: audience separation and one indication per submission (section V), clean and annotated versions and the accompanying PI (sections VI.F and VI.G), websites and interactive materials (section VI.E and the examples in section VII).
• FDA, eCTD Technical Conformance Guide, section 3.1.6, on HTML with scripts and PDF as the alternative.
• 21 CFR 202.1, prescription drug advertisements: (b)(1) established name type size, (e)(1) brief summary, (e)(5)(ii) fair balance.
• FDA, Instructions for completing Form FDA 2253, material types.

Written by the RouteShot Editorial Team from primary sources, cited inline. How we write and review guides · Report an error