Shared CPG must be based on a rigorous, transparent evidence review

Where this comes from

Section V, Q4, item 2.a (CPGs) · page 25. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…of evidence, with the goal of making treatment recommendations and describing the different levels of evidence that support those recommendations. CPGs provide recommendations for care for a disease or condition, in addition to offering potential alternatives for certain patient subgroups. FDA recommends that a CPG have all of the following characteristics if a firm chooses to include it in an SIUU communication: The CPG is based on rigorous reviews of the existing evidence conducted according to a clear, established procedure and following a transparent process that minimizes biases and conflicts of interest The CPG includes ratings of the recommendations to reflect the quality and strength of evidence that supports each recommendation The CPG is revised when important new evidence warrants modifications of current recommendations The CPG is generally available through independent distribution channels (e.g., internet sources, book retailers, subscriptions, libraries) where CPGs are sold or are accessible CPGs…

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

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a36a07e1efd950b7a2a8f6b3…

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