MLRagent
Rules/misleading presentation/US-MIS-034

Do not share reference texts or digital resource content that misrepresents or overstates findings

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

Rule

A reference text or digital clinical practice resource should not be shared in an SIUU communication if it misrepresents or overstates the findings of a study or analysis in light of that study's or analysis's limitations.

Check

Compare the resource's characterization of underlying evidence to that evidence's actual limitations. A violation is content that overstates or misrepresents the underlying study/analysis.

Escalate when

Whether a characterization amounts to overstatement is a matter of scientific judgment.

Where this comes from

Section V, Q4, item 2.b (Reference Texts / Digital Clinical Practice Resources) · page 27. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ustry and in accordance with any specific peer-review procedures of the publisher It is authored, edited, and contributed to by experts who have demonstrated expertise in the subject area(s) through education or experience It is generally available or sold through independent distribution channels (e.g., internet sources, book retailers, subscriptions, libraries) for medical and scientific educational content Reference texts or material(s) from digital clinical practice resources 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. Q5. What additional recommendations apply to firm-generated presentations of scientific information on unapproved use(s) provided with a source publication? In addition to sharing SIUU communications that include one or more source publications, some firms also develop firm-generated presentations to include in their SIUU communications. Because the firms themselves are not only choosing to initiate the sharin…
Open the original at page 27 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)
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
a36a07e1efd950b7a2a8f6b3…

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