Describe all material limitations of study design, methodology, and results

DisputedwarningFDA 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, among other things, all material limitations related to that study's design, methodology, and results.

Check

Identify known material limitations of the study (design, methodology, results) and confirm they are described if not already present in the source publication. A violation is a material limitation that goes undescribed.

Escalate when

Judgment is needed to decide whether a given limitation is 'material.'

Where this comes from

Section V, Q2 · page 20. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

This rule is one item of a list. The list is introduced by: 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:

…zes, 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> (reviewing 48 studies showing that “[s]ponsorship of drug and device studies by the manufacturing company leads to more favorable results and conclusions than sponsorship by other sources”). All material limitations related to the study design, methodology, and results. Any conclusions—from other scientifically sound studies that evaluated the same or similar hypotheses or research questions—that are in conflict with the conclusions from the studies or analyses described in the source publication(s). The citations for any such studies should also be included. The publication date of any referenced or included source publication (if not specified in the source publication or c…

Open the original at page 20 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

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: the Q2 list, under the same conditional stem, includes 'All material limitations related to the study design, methodology, and results.' The rule statement reproduces the conditional faithfully and keeps the recommendatory 'should'.
- The quote is the bare list item and drops the governing stem, so standing alone it is a fragment with no subject or verb and no indication of scope.
- Determinism 'judgment' is correct: whether a limitation is 'material' is an adequacy judgment, as the escalation clause says. Severity 'warning', authority 'guidance', scoping and the Q2 locator are correct.
- Single requirement; it is properly separated from US-DISC-007 (aspects vs. limitations are distinct list items in the source).
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Section V Q2 includes, under the study-focused lead-in, the sub-item 'All material limitations related to the study design, methodology, and results.' The rule restates this with both conditions (a study-focused source publication, and the information missing from it).
- The limitations sub-item is separated from the lead-in by the first sub-item and a footnote citation block.
- The rule uses 'should', so it is not overstated. Materiality needs judgment, so 'judgment' is correct. Severity, scope and locator are correct.
- The rule's quote is only the list's lead-in sentence, which several rules share. The quote therefore does not contain the item that establishes this rule. The verifier contract now provides a `lead_in` field for a list item that is not adjacent to its lead-in, so the quote can and should be the item itself.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim a sub-item of the Q2 list. The rule body correctly keeps both conditions: the source publication is primarily focused on a particular study, and the information is not already in the source publication.
- The quote does not show those conditions. They come from a nested introducing sentence that is not adjacent (the 'All material aspects...' item and footnote text come between), and there is no lead_in, so the quote alone looks unconditional.
- The title 'Describe all material limitations of study design, methodology, and results' is a bare command, and it also drops the condition that the information is missing from the source publication.
- Judgment is correct because 'material' requires assessment.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim a sub-item. The lead_in is the nested introducing sentence ('In the case of an SIUU communication that includes one or more source publications primarily focused on a particular scientific study... provide a description of:'), which sits inside the Q2 'FDA recommends that firms include all of the following' list. The rule statement correctly carries both conditions (a study-focused source publication, and the information missing from it) and uses 'should'.
- The title 'Describe all material limitations of study design, methodology, and results' is a bare command for a non-binding recommendation.
- Judgment is correct because materiality is a judgment call. applies_when and the locator are correct.

Nearby rules

US-DISC-005 US-DISC-006 US-DISC-007 US-DISC-009 US-IND-014 US-RISK-024 US-RISK-025 US-RISK-026 US-RISK-027 US-RISK-028 US-SUB-016