Shared reference text/digital resource should come from an independent scientific/medical publisher

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

Rule

A reference text or digital clinical practice resource included in an SIUU communication should be published by an independent publisher whose business is publishing scientific or medical educational content.

Check

Verify the publisher's independence and its business focus on scientific/medical educational content. A violation is content from a publisher tied to the firm's own commercial interests or not in that business.

Escalate when

Whether a publisher is genuinely independent of the firm (funding, ownership, editorial control, commercial ties) can require 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.

…u>. https://nap.nationalacademies.org/catalog/13059/finding-what-works-in-health-care-standards-for-systematic-reviews </u>. reflect the strength and quality of evidence supporting those CPG recommendations and that any CPG recommendations are updated when new evidence warrants modification. b. Specific Recommendations for Reference Texts and Materials From Digital Clinical Practice Resources: FDA recommends that a reference text or material from a digital clinical practice resource have all of the following characteristics if a firm chooses to include it in an SIUU communication: It is published by an independent publisher that is in the business of publishing scientific or 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…

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.

Applies when

Audiencehcp

Basisunapproved-use-scientific

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
- Supported: the bullet appears in Q4 item 2.b under 'FDA recommends that a reference text or material from a digital clinical practice resource have all of the following characteristics if a firm chooses to include it in an SIUU communication'.
- Not overstated; recommendatory modality and guidance authority are preserved.
- Atomic: 'independent publisher in the business of publishing scientific or medical educational content' is a single publisher-qualification characteristic yielding one finding.
- 'deterministic' is wrong. The core element is the publisher's independence, which the rule's own check asks the reviewer to 'verify' and which the check then glosses as a publisher 'tied to the firm's own commercial interests' - a relationship assessment, not a literal match. The corpus already treats the equivalent independence assessment as 'judgment' elsewhere (US-SCI-019 escalates on whether a publisher is 'truly independent'), so this label is also internally inconsistent.
- Locator, applies_when and 'warning' severity are defensible.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Q4 item 2.b says 'FDA recommends that a reference text or material from a digital clinical practice resource have all of the following characteristics if a firm chooses to include it in an SIUU communication', the first being publication by an independent publisher in the business of scientific/medical educational content. The rule text says 'should', but the title says 'must come from', overstating the recommendation.
- The quote 'It is published by an independent publisher ...' is a bare list item whose subject 'It' is undefined without the lead-in; the lead-in immediately precedes it and can be included verbatim.
- Independence and business focus are stated as one characteristic in the source, so the rule is atomic; judgment is correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote joins the introducing sentence and the adjacent first list item of Q4 item 2.b, verbatim and complete. The recommendation framing is visible.
- The rule and title use 'should' and follow the source (an independent publisher in the business of publishing scientific or medical educational content).
- The rule is atomic because it covers only the publisher characteristic. Judgment is correct because independence requires assessment. The locator is correct.

Nearby rules

US-MIS-034 US-SCI-029 US-SCI-030 US-SCI-031