Qualified personnel should review CFL promotional communications before dissemination

AI-verifiednoteFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

FDA recommends that firms have qualified medical/scientific, legal, and regulatory personnel review a CFL promotional communication before it is disseminated, to help ensure it is not false or misleading.

Check

This is a workflow/process check evaluated against review-record metadata, not against the content of the communication itself. Confirm that a dated medical/scientific, legal, and regulatory (MLR) review sign-off record exists for the piece, dated prior to its dissemination date. A violation looks like a piece scheduled for or already in dissemination with no dated sign-off record covering all three disciplines (medical/scientific, legal, and regulatory) prior to the dissemination date.

Escalate when

Escalate when no review record can be located for the piece, or the record is missing sign-off from one of the three required disciplines (medical/scientific, legal, or regulatory).

Where this comes from

Q.8/A.8, concluding paragraph · page 18. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ents that have been observed in practice, the communication should also include information from the FDA-required labeling about the types and rates of occurrence of adverse reactions observed in clinical trials to provide context. These considerations are not intended to be a comprehensive description of everything a firm should factor into its analysis of whether its presentations are truthful and non-misleading. FDA recommends that, before disseminating a CFL promotional communication, firms should have qualified medical/scientific, legal, and regulatory personnel carefully review the communication to ensure it is not false or misleading. Q.9. What are some examples of promotional communications that are consistent with the FDA-required labeling and with the recommendations in this guidance? A.9. The following are two examples of promotional communications FDA would consider to be consistent with the FDA-required labeling and the recommendations in Q.6/A.6 and Q.8/A.8. Example 1: Product B is an Immune Globulin Intravenous (Human), 10% liq…

Open the original at page 18 on fda.gov ↗Read our full copy →

Document: FDA guidance: Medical Product Communications that Are Consistent With the FDA-Required Labeling – Questions and Answers (final)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: 1a18b7f242bfbbf897f198df…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Naturepromotional

Basisconsistent-with-labeling

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 quote is verbatim from the concluding paragraph of A.8 and the locator ('Q.8/A.8, concluding paragraph') is exactly right. The rule statement preserves the recommendation framing ('FDA recommends that firms have ...'), so it is not overstated.
- applies_when is not justified as written. The source sentence expressly conditions on 'before disseminating a CFL promotional communication', and the rule's own title says 'CFL promotional communications', but applies_when encodes only promotional and omits the basis: consistent-with-labeling limit that sibling rule US-SUB-008 carries. The obvious limit stated in the source text is missing from the machine-readable condition.
- 'deterministic' is defensible for the Check as written (a documented medical/scientific, legal and regulatory sign-off either exists before dissemination or it does not), but the rule's substance includes 'qualified' personnel and 'carefully review ... to ensure it is not false or misleading', neither of which a presence check settles. The Check should be explicitly narrowed to the existence of the review record so the deterministic flag is honest.
- This is a process control, not a property of the communication. Nothing in the piece under review reveals whether MLR review occurred, so a content reviewer cannot check it from the artifact — it is checkable only against workflow metadata. That is a real limitation but not a reason to reject, since an MLR system does hold that metadata; it should be labelled so it is not routed to a content-only checker.
- Category 'submission' mischaracterizes the rule: nothing is submitted to FDA here; this is an internal pre-dissemination review control. Severity 'note' is defensible for a high-level recommendation.
- The rule is missing an 'Escalate when' section, which every other rule in this packet has.
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 complete concluding sentence of Q.8/A.8 and is verbatim in the source; it carries its own subject and does not run into adjacent text.
- Supported: the sentence establishes exactly what the rule states — pre-dissemination review by qualified medical/scientific, legal, and regulatory personnel of a CFL promotional communication.
- Not overstated: the rule keeps FDA's 'recommends/should' framing and does not convert the recommendation into an obligation, and it keeps the purpose clause as 'to help ensure it is not false or misleading' rather than promising that review guarantees compliance.
- Atomic: one requirement — that a pre-dissemination review by those disciplines occurred. The three disciplines are the composition of a single review, not three independent obligations.
- Determinism 'deterministic' is acceptable as the rule is operationalized: the check is explicitly a workflow/metadata test (does a dated sign-off record covering the three disciplines exist before the dissemination date?), which presence/absence settles. The evaluative-sounding words in the source sentence ('qualified', 'carefully') are not what the check asks a reviewer to weigh.
- Authority 'guidance' matches the source document, and the rule claims no more; it is not a restatement of a statute or regulation quoted by the guidance. applies_when (promotional, consistent-with-labeling) matches the sentence's explicit subject, 'a CFL promotional communication', and the locator points to the right paragraph.
- Violable and severity defensible: a piece can be disseminated with no such review, so this is a real rule rather than a definition or carve-out, and 'note' is appropriate for a process recommendation that is checked against records rather than content.