MLRagent
Rules/scientific exchange/US-SCI-021

Reprinted article or its journal must be generally available through independent channels

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

Rule

A reprint shared by a firm should be from an article (or journal) that is generally available through independent distribution channels such as internet sources, book retailers, subscriptions, or libraries.

Check

Confirm the article or journal can be independently obtained through normal distribution channels. A violation is sharing a reprint that is not otherwise available outside the firm's own distribution.

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.

…ial 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., internet sources, book retailers, subscriptions, libraries) where periodicals and reprints are sold or are accessible Articles that misrepresent or overstate findings from a study or analysis in light of the limitations of such study or analysis would not fall within the enforcement policy outlined in this guidance. 2. Clinical Reference Resources: In this guidance, we address the following clinical reference resources: CPGs Reference texts Materials from digital clinical practice resources These c…
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.