Reprint's journal should be managed by an independent organization

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

Rule

A reprint shared by a firm should come from a journal managed by an independent organization.

Check

Verify that the journal is managed by an independent organization. A violation is a reprint from a journal not managed by an independent organization.

Escalate when

Assessing whether a publisher/organization is truly 'independent' can require judgment.

Where this comes from

Section V, Q4, item 1 (Reprints) · page 23. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…igital clinical practice resources that are included in an SIUU communication, in addition to the recommendations outlined in Q1, Q2, and Q3. 1. Reprints: When firms share SIUU communications that include one or more reprints, the reprints should be unaltered/unabridged because the sharing of unaltered/unabridged articles is less likely to introduce bias or result in the omission of material information. Moreover, FDA recommends that the articles that firms choose to share as reprints have the following characteristics: The article is published in a journal managed by an independent organization that has an editorial board composed of persons who have demonstrated expertise in the subject of the articles under review by the organization (through education or experience) and that has a publicly stated policy regarding the disclosure of conflicts of interest or biases for all authors, contributors, and editors The article is peer-reviewed by experts in the subject of the article, as established by educatio…

Open the original at page 23 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
- The source bullet is present and supports the content: FDA recommends that articles shared as reprints have this journal characteristic.
- Not overstated - the rule stays in 'should' form and does not claim more than the guidance.
- Not atomic: the rule bundles three requirements that can fail independently of one another - (1) the journal is managed by an independent organization, (2) its editorial board is composed of demonstrated subject-matter experts, and (3) the organization has a publicly stated COI/bias disclosure policy covering authors, contributors and editors. The rule's own check enumerates all three and defines a violation as 'lacking any of these characteristics', which confirms three separable findings with different remediations.
- 'judgment' is correct for the independence and expertise elements, and the escalate note is appropriate.
- Locator (Q4, item 1) and applies_when are correct; severity 'warning' is defensible.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The source (Q4 item 1) establishes this as one of the characteristics FDA 'recommends' for articles shared as reprints; the rule text correctly says 'should', but the title says 'must be managed', turning a non-binding recommendation into an obligation.
- The quote is a bare list item ('The article is published in a journal ...') stripped of its lead-in 'Moreover, FDA recommends that the articles that firms choose to share as reprints have the following characteristics:', so on its own it reads as a factual statement rather than a recommendation and does not show the reprint context.
- The quote also carries two further characteristics (editorial-board expertise; public conflict-of-interest policy) that this rule does not address and that are covered as separate rules; the rule itself is atomic (independence only).
- Judgment is correct: whether an organization is 'independent' is not a literal-match test.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote includes its introducing sentence ('FDA recommends that the articles that firms choose to share as reprints have the following characteristics:') together with the first list item, so it reads correctly as a recommendation. It is truncated before the item's further clauses (editorial board expertise, conflict-of-interest policy), but it keeps its subject and does not change the meaning of the independence characteristic.
- The rule and title use 'should', which is faithful to guidance authority.
- The rule is atomic because it covers only independence, leaving the editorial-board and conflict-of-interest characteristics to separate checks.
- Judgment is correct because independence requires assessment, and the escalation note is appropriate.

Nearby rules

US-MIS-032 US-SCI-018 US-SCI-020 US-SCI-021 US-SCI-036 US-SCI-037