Use reprints only from journals with a stated conflict-of-interest disclosure policy

Where this comes from

Section V, Recommendation 3 · page 11. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…equest, not just summary documents or abstracts prepared by the firm. The response can include unpublished data on file if they are responsive to the specific request (either supporting or casting doubt on the safety or efficacy of the off-label use). However, to the greatest extent possible, a firm should rely on published peer-reviewed journal articles, medical texts, or data derived from independent sources. To the extent the response consists of published reprints from journals, those reprints should be from journals that have a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors, contributors, or editors associated with the journal or organization. 4. Information distributed in response to an unsolicited request should be scientific in nature. When responding to an unsolicited request for information, a firm should respond with material that is scientific in tone and presentation. The material should not be promotional in tone or presentation. Furthermore, the responsive material should not be distributed along with other material or information that is p…

Document

FDA guidance: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (see document)

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as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file

Retrieved

2026-09-21 from www.fda.gov

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FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.