Reprint's journal editorial board should have demonstrated expertise

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

Rule

A reprint shared by a firm should come from a journal whose editorial board is composed of persons who have demonstrated expertise, through education or experience, in the subject of the articles under review by the organization.

Check

Verify that the journal's editorial board members have demonstrated subject-matter expertise through education or experience. A violation is a reprint from a journal whose editorial board lacks demonstrated expertise in the relevant subject area.

Escalate when

Assessing whether an editorial board has 'demonstrated expertise' 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 education or experience The article is generally available (or the journal from which the article is taken is generally available) through independent distribution channels (e.g., int…

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
- Q4 item 1 lists editorial-board expertise as part of a characteristic FDA 'recommends' for articles shared as reprints; the rule text says 'should', but the title says 'must show', overstating a recommendation.
- The quote is a bare list item without its lead-in ('Moreover, FDA recommends that the articles that firms choose to share as reprints have the following characteristics:'), so it reads as a factual statement rather than a recommendation; it also carries the independence and conflict-of-interest elements that belong to other rules.
- The rule itself addresses only editorial-board expertise, so it 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
- Q4 item 1 (Reprints): '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)'. The lead-in and the item are adjacent, so one quote is correct, and it ends at a clause boundary without losing its subject.
- The rule isolates the editorial-board-expertise characteristic only; the conflict-of-interest policy characteristic is a separate rule (US-SCI-037), so this is atomic and not a duplicate.
- 'Should' preserves the 'FDA recommends' framing. Judgment is correct because 'demonstrated expertise' calls for assessment. applies_when and locator are right.

Nearby rules

US-SCI-019 US-MIS-032 US-SCI-018 US-SCI-019 US-SCI-020 US-SCI-021 US-SCI-037