Shared reference text/digital resource must follow accepted content-creation and peer-review standards

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 consistent with current, industry-accepted standards for medical content creation and review, including the publisher's own peer-review procedures.

Check

Check the publisher's stated review/editorial standards against industry norms and its own peer-review procedures. A violation is content that bypassed the publisher's own stated review process.

Escalate when

Assessing whether standards are 'generally accepted by the medical publishing industry' requires 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.

…cific 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 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 misr…

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the complete bullet from Q4 item 2.b and supports the rule as stated, including the publisher's own peer-review procedures, which the source names in the same clause.
- Not overstated: 'should be published consistent with ...' matches the guidance's recommendatory framing; the rule does not claim binding force.
- Atomic: one publishing-standards characteristic - the source joins the industry standards and the publisher's own peer-review procedures in a single condition describing how the content was produced.
- 'judgment' is correct, since conformity with standards 'generally accepted by the medical publishing industry' is an adequacy assessment; the escalate note says exactly this.
- applies_when, the Q4 item 2.b locator and 'warning' severity are appropriate. The check's opening sentence covers both the industry-norms and publisher-procedure elements, so the narrower final sentence is a wording preference, not a defect.

Nearby rules

US-MIS-034 US-SCI-028 US-SCI-030 US-SCI-031