MLRagent
Rules/scientific exchange/US-SCI-031

Shared reference text/digital resource must be generally available through independent channels

AI-verifiedwarningFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

A reference text or digital clinical practice resource included in an SIUU communication should be generally available or sold through independent distribution channels for medical/scientific educational content.

Check

Confirm the resource is independently obtainable outside the firm's own distribution. A violation is content not otherwise generally available or sold through such channels.

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.

… medical educational content It is published in a manner consistent with current standards for medical content creation and review that are generally accepted by the medical publishing industry 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 publicat…
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.