Share reprints unaltered and unabridged

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

Rule

Reprints included in an SIUU communication should be shared unaltered and unabridged.

Check

Compare the shared reprint against the original published article for completeness. A violation is any alteration, abridgment, or omission from the original article.

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.

…ommendations apply to reprints, CPGs, reference texts, and materials from digital clinical practice resources that are included in an SIUU communication? This section offers specific recommendations regarding reprints, CPGs, reference texts, and materials from digital 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 regar…

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence from Q4 item 1 and directly states the recommendation the rule expresses: reprints included in an SIUU communication should be unaltered/unabridged.
- The rule keeps the guidance's recommendatory modality ('should be shared unaltered and unabridged') and does not convert an FDA recommendation into a prohibition, so it is not overstated and the 'guidance' authority is not exceeded.
- 'Unaltered/unabridged' is a single fidelity requirement as the source phrases it, not two independently remediable obligations, so the rule is atomic.
- 'deterministic' is right: the check is a literal comparison of the shared reprint against the published article; alteration or omission is settled by comparison, not by impression.
- applies_when (HCP audience, unapproved-use-scientific basis) matches the guidance's own scope (firm communications to HCPs about unapproved uses of approved/cleared products); 'warning' severity is defensible for an enforcement-policy condition; the locator matches Q4, item 1 (Reprints).

Nearby rules

US-MIS-032 US-SCI-019 US-SCI-020 US-SCI-021 US-SCI-036 US-SCI-037