Accurately represent study results relied upon

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

Rule

FDA recommends that any study results or other data relied upon to support a CFL promotional communication (labeling, or prescription drug / restricted device advertising, that is consistent with the FDA-required labeling) be accurately represented in the communication.

Check

Compare the piece's characterization of study results to the actual study data/results. A violation looks like a mischaracterized endpoint, effect size, or outcome.

Escalate when

The characterization is technically correct but creates a different impression than the underlying data.

Where this comes from

Q.8/A.8, bullet 1 · page 17. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…the FDA-required labeling (including the express and implied claims made and the overall impression created by the communication as a whole) affects how the information is understood. The following are some high-level recommendations for firms to consider when developing their presentations of information in CFL promotional communications to help ensure the presentations do not mislead the applicable audience(s): Any study results or other data and information that are relied upon to support a firm’s CFL promotional communication should be accurately represented in the communications. Moreover, aspects of study design and methodology that are material for audiences to accurately interpret the information presented (e.g. type of study, study objectives, product dosage/use regimens, controls used, patient population studied) from any studies relied on should be clearly and prominently disclosed in firms’ CFL promotional communications, and material limitations related to the study design, methodolo…

Open the original at page 17 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 first bullet of A.8 supports the substance: 'Any study results or other data and information that are relied upon to support a firm's CFL promotional communication should be accurately represented in the communications.' The rule correctly keeps the non-binding framing ('FDA recommends'), matching the guidance's own statement that 'should' means 'suggested or recommended, but not required.'
- Scope is broader than the source. The rule and its applies_when reach every promotional communication, but the source expressly limits these recommendations: 'These general recommendations for conveying information in a truthful and non-misleading way are applicable only to drug and device labeling and prescription drug and restricted device advertising that are consistent with the FDA-required labeling (... CFL promotional communications).' Every bullet in A.8 is written about 'a firm's CFL promotional communication.' The packet's own sibling rule US-CMP-003 carries the basis limiter, so the facet exists and is simply missing here; without it the rule will fire on communications this source says nothing about.
- One requirement (accurate representation of relied-upon results), so atomic. 'Judgment' is right, since accuracy of characterization turns on impression and interpretation, not a literal match. 'Guidance' is correct. Locator 'Q.8/A.8, bullet 1' is accurate and the quote is verbatim. Severity 'warning' is on the low side for a mischaracterized efficacy result, but it is defensible and not grounds to withhold a pass by itself.
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 first sentence of the first bullet of Q.8/A.8 and directly establishes the requirement stated.
- Not overstated: the source's 'should' is carried through as 'FDA recommends,' and the rule keeps the source's scope by defining CFL promotional communications as labeling, or prescription drug / restricted device advertising, consistent with the FDA-required labeling — the exact limit stated in section II.
- Atomic: one requirement (accurate representation of relied-upon results), separate from the disclosure duties carved into US-DISC-002 and US-DISC-003 from the rest of the same bullet.
- Determinism 'judgment' is right: whether a characterization is accurate turns on the impression it creates relative to the underlying data, as the escalation condition recognizes.
- Authority 'guidance' matches the document, and the rule does not restate a statute or regulation that the guidance quotes. applies_when and the Q.8/A.8 bullet-1 locator are both correct, and 'warning' is defensible for a category that spans trivial imprecision to material mischaracterization.

Nearby rules

US-DISC-002 US-DISC-003