Describe all material aspects of study design, methodology, and results for study-focused source publications

AI-verifiedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

When an SIUU communication includes a source publication primarily focused on a particular study, and the source publication itself does not include this information, the communication should provide a description of all material aspects of that study's design, methodology, and results.

Check

Confirm the source publication already covers study design, methodology, and results; if not, check that the SIUU communication supplies the missing material aspects. A violation is a study-focused source publication with an incomplete description of design, methodology, or results, uncorrected by the communication.

Escalate when

Judgment is needed to decide whether a given omitted detail is 'material' to interpreting the study.

Where this comes from

Section V, Q2 · page 19. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…should disclose that fact and should describe the goal(s) of the REMS A statement identifying any authors, editors, or other contributors to publication(s) included in the SIUU communication who were employees of or consultants to or who received compensation from the firm at the time of writing, editing, or contributing to the publication, to the extent a firm acting reasonably would know of such relationship In the case of an SIUU communication that includes one or more source publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of: All material aspects of study design, methodology, and results. https://doi.org/10.1136/bmj.326.7400.1167 </u> (reviewing 30 studies finding that “[s]ystematic bias favours products which are made by the company funding the research.”); Lundh, A., Lexchin, J., Mintzes, B., Schroll, J. B., & Bero, L. (2017). Industry sponsorship and research outcome. The Cochrane database of systematic reviews, 2(2), MR000033. <u> https://doi.org/10.1002/14651858.MR000033.pub3 </u> (reviewi…

Open the original at page 19 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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The rule statement correctly reproduces the full conditional from Q2 — a source publication primarily focused on a particular study, and the information not already included in that source publication — before requiring a description of all material aspects of study design, methodology and results.
- The quote, however, is only the trailing list item ('All material aspects of study design, methodology, and results.'). It drops the entire conditional stem that the rule relies on ('In the case of an SIUU communication that includes one or more source publications primarily focused on a particular scientific study or studies, for each such study where the following information is not included in the source publication, provide a description of:'), so the quote does not by itself show the scope or the obligation.
- Determinism 'judgment' is correct — 'material' aspects turn on adequacy, as the escalation clause states. Severity 'warning', authority 'guidance', audience/basis scoping and the Q2 locator are correct.
- Treated as a single requirement (one Q2 list item covering the study's design, methodology and results together), which is how the source frames it.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the conditional lead-in together with its first sub-item ('All material aspects of study design, methodology, and results.'). It appears verbatim and contiguously in Section V Q2, so it is not a bare list item.
- The rule keeps both conditions: the source publication is primarily focused on a particular study, and the information is not already in the source publication. It uses 'should', which is consistent with the Q2 recommendation framing ('FDA recommends that firms include all of the following').
- Design, methodology and results appear together as one sub-item in the source, so the rule is atomic as drafted. Deciding what is 'material' calls for judgment, so 'judgment' is correct. Severity, scope and locator are correct.

Nearby rules

US-DISC-005 US-DISC-006 US-DISC-008 US-DISC-009 US-IND-014 US-RISK-024 US-RISK-025 US-RISK-026 US-RISK-027 US-RISK-028 US-SUB-016