Data relied on must be scientifically appropriate and statistically sound

AI-verifiedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

FDA recommends that any data, studies, or analyses a firm relies on to support a claim in a CFL promotional communication be scientifically appropriate and statistically sound for that specific claim.

Check

For each claim, identify the supporting study/analysis and assess whether its design and statistical methods actually support the specific claim made. A violation looks like a claim resting on a study not designed or powered to support it.

Escalate when

Always for study adequacy questions — requires biostatistical/medical judgment.

Where this comes from

Q.6/A.6 · page 14. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…hat are material about the product being promoted, including information about the risks of the product. When these communications lack appropriate evidentiary support, they are likely to be false or misleading and can cause patient harm. To be truthful and non-misleading, representations or suggestions made by firms about their products need to be grounded in fact and science and presented with appropriate context. Any data, studies, or analyses relied on should be scientifically appropriate and statistically sound to support the representations or suggestions made in a CFL promotional communication. Contains Nonbinding Recommendations The safety and effectiveness of the drug or device under the conditions of use in the FDA-required labeling have already been established by appropriate evidence during the premarket review process (and/or through the device classification process). Therefore, FDA would not consider representations or suggestions in a CFL promotional communication to be false…

Open the original at page 14 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

Basisconsistent-with-labeling

Naturepromotional

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim from the closing sentence of the first paragraph of A.6 ('Any data, studies, or analyses relied on should be scientifically appropriate and statistically sound to support the representations or suggestions made in a CFL promotional communication.'). It is a direct FDA recommendation in the body of the answer, not an example, a definition, or a description of what is not required, and the rule statement follows from it directly.
- Not overstated: the source says 'should' and the rule says 'FDA recommends that ... be', preserving the non-binding character of a document headed 'Contains Nonbinding Recommendations'. The rule also does not convert this into an approval-standard requirement, which matters because the next paragraph of A.6 expressly says FDA would not find a CFL communication misleading based only on failure to meet the approval/clearance evidentiary standard.
- The added phrase 'for that specific claim' is supported rather than invented: the source ties the adequacy of the evidence to 'the representations or suggestions made', and the following paragraph states that the amount and type of evidence needed depends on the topic and on the particular representations made.
- Atomic: 'scientifically appropriate and statistically sound' are conjoined criteria of a single adequacy determination in the source and are exercised by one assessment in the Check (does this study's design and statistical method support this claim). Splitting them would be an artificial division not made by the source.
- 'judgment' is correct — scientific appropriateness and statistical soundness turn on adequacy, not on presence/absence or a literal match, and the escalation note ('Always for study adequacy questions') is consistent with that.
- 'guidance' is correct for authority: A.6 is an FDA recommendation, not statute or regulation, and the rule does not assert binding force.
- applies_when is justified and complete: basis consistent-with-labeling and promotional both come straight from the quoted sentence's own terms ('a CFL promotional communication'). Locator Q.6/A.6 is correct, and severity 'warning' is defensible for a recommendation whose breach makes the communication likely to be misleading rather than automatically unlawful.

Nearby rules

US-MIS-022 US-MIS-023 US-MIS-024 US-MIS-025 US-MIS-056