MLRagent
Rules/misleading presentation/US-MIS-032

Do not share reprints that misrepresent or overstate their findings

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

Rule

An article should not be shared as a reprint in an SIUU communication if it misrepresents or overstates the findings of its study or analysis in light of that study's or analysis's limitations.

Check

Compare the article's stated findings against the underlying data and limitations. A violation is a reprint whose conclusions overstate or misrepresent what the study/analysis actually supports.

Escalate when

Whether a characterization amounts to 'overstating' findings is a matter of scientific judgment.

Where this comes from

Section V, Q4, item 1 (Reprints) · page 24. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…editors The article is peer-reviewed by experts in the subject of the article, as established by education or experience The article is generally available (or the journal from which the article is taken is generally available) through independent distribution channels (e.g., internet sources, book retailers, subscriptions, libraries) where periodicals and reprints are sold or are accessible Articles that misrepresent or overstate findings from a study or analysis in light of the limitations of such study or analysis would not fall within the enforcement policy outlined in this guidance. 2. Clinical Reference Resources: In this guidance, we address the following clinical reference resources: CPGs Reference texts Materials from digital clinical practice resources These clinical reference resources often contain information about unapproved uses of approved/cleared medical products. Therefore, when sharing SIUU communications that include CPGs, reference texts, or materials from digital…
Open the original at page 24 on fda.gov ↗Read our full copy →
Document
FDA guidance: Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (final)
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as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved
2026-09-21 from www.fda.gov
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FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.