MLRagent
Rules/scientific exchange/US-SCI-023

Excerpted clinical reference resource sections must be unaltered and extracted directly

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

Rule

Individual sections shared from a CPG, reference text, or digital clinical practice resource should be unaltered, unabridged, and extracted directly from the original resource.

Check

Compare the shared section text against the original resource. A violation is any editing, abridgment, or indirect (e.g., re-typed/paraphrased) reproduction of the section.

Where this comes from

Section V, Q4, item 2 (Clinical Reference Resources) · page 24. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…sources, the SIUU communication should include all information from the clinical reference resource necessary for HCPs to interpret the strengths and weaknesses, validity, and clinical utility of the scientific information on unapproved use(s) that the clinical reference resource presents. This may involve the sharing of multiple sections of the clinical reference resource that contain related or linked information. When a firm shares individual section(s) from these clinical reference resources, those individual section(s) should be unaltered/unabridged and extracted directly from the clinical reference resource. Because unabridged CPGs and reference texts in their entirety generally discuss a wide range of topics and medical products, FDA notes the following modifications to the recommendations in Q2. When a firm shares an SIUU communication that does not include a firm-generated presentation, but does include an unabridged CPG or reference text in its entirety that discusses a wide range of medical products and that discu…
Open the original at page 24 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.