Disclose material limitations of study design, methodology, and results

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

Rule

FDA recommends, for CFL promotional communications (labeling, or prescription drug / restricted device advertising, consistent with the FDA-required labeling), that material limitations related to a relied-upon study's design, methodology, and results be disclosed clearly and prominently.

Check

Check whether known material limitations (e.g., small sample, not powered, retrospective, non-randomized) are disclosed clearly and prominently, not buried in fine print. A violation looks like limitations omitted entirely or presented in illegible/inconspicuous form.

Escalate when

Whether a given limitation is 'material' requires medical/scientific judgment.

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.

…ion 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, methodology, and results should also be disclosed in a clear and prominent manner. The CFL promotional communication should accurately characterize and contextualize the relevant information about the product, including by disclosing unfavorable or inconsistent findings. For example, if a firm presents efficacy results from a postmarketing study of its product that evaluated the effect of the product on two different endpoints, such as overall survival and progression-free survival, and the pro…

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
- Directly supported by the closing clause of A.8 bullet 1: 'material limitations related to the study design, methodology, and results should also be disclosed in a clear and prominent manner.' The quote is verbatim and the locator is right. The rule preserves the non-binding 'FDA recommends' framing.
- Scope is broader than the source: the applies_when reaches all promotional communications, while the guidance states these recommendations apply only to labeling and prescription drug / restricted device advertising that is consistent with the FDA-required labeling. The sibling rule US-CMP-003 shows the basis facet is available.
- 'Design, methodology, and results' is a single disclosure obligation over one relied-upon study, not independently checkable requirements, so atomic is correct. 'Judgment' is right: both 'material' and 'clear and prominent' turn on scientific judgment and prominence (see footnote 25 of the source). 'Guidance' is correct and 'warning' is defensible.
- The Check's illustrative limitations (small sample, not powered, retrospective, non-randomized) are consistent with how the source itself illustrates limitations elsewhere (e.g., 'not prespecified and appropriate multiplicity adjustments were not applied ... need cautious interpretation').
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 a complete independent clause with its own subject ('material limitations related to the study design, methodology, and results should also be disclosed in a clear and prominent manner') and does not run into unrelated material.
- Supported: Q.8/A.8 bullet 1 states this directly, and Q.6/A.6 reinforces it ('fail to disclose their material limitations' makes a communication not truthful and non-misleading).
- Not overstated: rendered as an FDA recommendation, with the CFL scope stated explicitly and correctly.
- Atomic: one requirement — disclose material limitations clearly and prominently. 'Design, methodology, and results' are the loci of a single limitations disclosure, not independently checkable obligations.
- Determinism 'judgment' is correct: materiality of a limitation and clear-and-prominent presentation are both impression/prominence questions. Authority 'guidance' matches the source, and the locator, applies_when and 'warning' severity are defensible.

Nearby rules

US-DISC-001 US-DISC-002