Submit promo materials for FDA review if disseminated within 120 days of approval

AI-verifiedblockerBinding lawCheckable — presence or a literal match settles it

Rule

For a drug being considered for approval under the accelerated approval subpart, the applicant must submit to FDA, for consideration during the preapproval review period, copies of all promotional materials (including promotional labeling and advertisements) that are intended for dissemination or publication within 120 days after marketing approval, unless FDA has otherwise informed the applicant.

Check

Confirm that any promotional piece intended for dissemination or publication within the first 120 days after approval of an accelerated-approval drug was submitted to FDA during the preapproval review period. A violation is a piece intended for dissemination or publication within the first 120 days after approval for which no submission was made to FDA during the preapproval review period.

Escalate when

Escalate if it is unclear whether FDA 'otherwise informed' the applicant of a different submission requirement, or whether the drug's approval falls under this accelerated-approval subpart.

Where this comes from

21 CFR 314.550. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… § 314.550 Promotional materials. For drug products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisements, intended for dissemination or publication within 120 days following marketing approval. After 120 days following marketing approval, unless otherwise informed by the agency, the applicant must submit promotional materials at least 30 days prior to the intended time of initial dissemination of the labeling or initial publication of the advertisement. …

Open the original at these words on ecfr.gov ↗Read our full copy →

Document: 21 CFR 314.550
Version: 2026-09-16 — the link above is pinned to this date, so it shows the text as it stood then
Retrieved: 2026-09-21 from www.ecfr.gov
Fingerprint: f6b458c68a5547f47c650231…

Applies when

Approval pathwayaccelerated

Productdrug

Naturepromotional

Launch stagepre-approvalpost-approval

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The core obligation is supported: the source text imposes a mandatory ('must submit') preapproval-period submission of copies of all promotional materials, including promotional labeling and advertisements, intended for dissemination or publication within 120 days following marketing approval, subject to the 'unless otherwise informed by the agency' carve-out, which the rule statement correctly carries over.
- The Check overstates the source. It requires that the piece was 'submitted to and reviewed by FDA during the preapproval period before dissemination.' The source requires only submission 'for consideration'; it does not require that FDA actually completed a review, and it does not condition dissemination on the outcome or completion of any FDA review. As written, a reviewer would fail a piece that was properly submitted but that FDA had not yet acted on, which the regulation does not prohibit.
- The Check also restates the violation as 'dissemination within that 120-day window without prior submission during preapproval review,' which shifts the trigger from the regulation's 'intended for dissemination or publication within 120 days' to actual dissemination. This is a narrowing that lets an unsubmitted piece that was intended for early use but slipped past day 120 escape the rule, and it misstates when the duty attaches (at the time of the preapproval review period, based on intent).
- Atomicity is fine: this is a single submission requirement with a single timing condition, not a bundle.
- Determinism 'deterministic' is defensible: the question is whether a submission record exists for the piece within the preapproval review period, which is settled by presence or absence, not by impression, adequacy or balance. The only soft element is the 'intended for dissemination within 120 days' scoping, which is a scope condition rather than the checked fact.
- Authority 'binding' is correct: 21 CFR 314.550 is a codified regulation.
- Severity 'blocker' is defensible: an unsubmitted piece cannot lawfully be disseminated, so the failure stops release rather than merely requiring edits.
- Locator '21 CFR 314.550' matches the section quoted.
- applies_when is mostly justified, with one caveat: the excerpt says 'under this subpart' and never uses the words 'accelerated approval', so the 'approval-pathway: accelerated' scope rests on the citation (314.550 sits in the accelerated approval subpart) rather than on the source text shown. That is acceptable, but the 'launch-stage: pre-approval' tag is in tension with the Check, which is written to be run against pieces slated for use after approval; the two should be reconciled so the rule fires at the point where a reviewer can actually apply it.
- The Escalate-when clause is appropriate and tracks the two genuinely uncertain elements in the text (the agency 'otherwise informed' carve-out and whether the product falls under this subpart).
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the operative first sentence of 21 CFR 314.550 and the locator matches. The language is mandatory ('applicants must submit to the agency for consideration during the preapproval review period'), so an obligation-shaped rule is faithful and not overstated.
- The rule preserves the two qualifiers that are easiest to drop: the 'unless otherwise informed by the agency' exception, and the limitation to materials 'intended for dissemination or publication within 120 days following marketing approval'. It does not extend the preapproval submission duty to all promotional material.
- Atomic: the rule covers only the preapproval 120-day submission and leaves the second sentence of § 314.550 (submission at least 30 days before initial dissemination after the first 120 days) to a separate rule. It does not claim to cover both regimes.
- The applies_when restriction to the accelerated approval pathway is a narrowing, not an invention: the source's own scope is 'drug products being considered for approval under this subpart', and § 314.550 sits in the subpart H accelerated-approval provisions that the cited section number identifies. The escalate condition additionally routes the pathway question to a human, so the narrowing cannot be applied blindly.
- launch-stage covering both pre-approval and post-approval is justified by the structure of the obligation: the submission happens during the preapproval review period while the material itself is destined for post-approval dissemination.
- 'Deterministic' is acceptable: the violation is a piece intended for dissemination in the first 120 days for which no preapproval submission was made — a presence/absence question about a submission record, not an assessment of impression, adequacy, prominence or balance. The residual uncertainties (whether FDA 'otherwise informed' the applicant, and whether the approval is under this subpart) are prerequisites the rule explicitly escalates rather than judgments folded into the check itself.
- Authority 'binding' is correct (codified FDA regulation) and 'blocker' is defensible for a mandatory preapproval submission requirement.

Nearby rules

US-ADM-008