Conclusions in a source publication should align with the study's prespecified hypothesis or research question

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

Rule

FDA recommends that any conclusions articulated in a source publication included in an SIUU communication align with the prespecified hypothesis or research question from the described study or analysis.

Check

Compare the source publication's stated conclusions against the study or analysis's prespecified hypothesis or research question. Flag a conclusion about something the study or analysis did not set out to test.

Escalate when

Whether a stated conclusion falls outside the study's prespecified hypothesis or research question turns on scientific or clinical judgment.

Where this comes from

Section V, Q1, item 3 · page 18. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…binding Recommendations Not for Current Implementation—see PRA statement in section VI. firm has shared on the internet an SIUU communication that includes a source publication that is no longer consistent with the recommendation that firms take into account existing scientific knowledge, and the firm has the ability to remove its SIUU communication, we recommend the firm remove its SIUU communication. 3. Any conclusions articulated in a source publication should align with the prespecified hypothesis or research question from the described study or analysis and be supported by the results from that study or analysis. Q2. What information should firms include as part of SIUU communications? FDA recommends that firms include all of the following information as part of SIUU communications: A statement that the unapproved use(s) of the medical product has not been approved by FDA and that the safety and effectiveness of the medical product for the unapproved use(s) has not been established For example, a statement that "…

Open the original at page 18 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 quote is the complete text of Q1 item 3 and the rule statement restates it faithfully in 'should' voice, so it is supported and not overstated.
- It is not atomic: the source sentence joins two independently checkable requirements — (a) the conclusions align with the prespecified hypothesis or research question, and (b) the conclusions are supported by the results. A publication can satisfy either one while failing the other (a conclusion can answer exactly the prespecified question yet outrun the data, or be well supported by the data yet address something the study never set out to test). A reviewer checking these performs two distinct comparisons against two different parts of the publication.
- Judgment determinism is correct — whether a conclusion is 'supported by the results' is a statistical/clinical call, as the escalation trigger acknowledges.
- Authority 'guidance' is correct and the rule claims no more than the guidance's non-binding recommendation.
- applies_when (HCP, unapproved-use-scientific), locator 'Section V, Q1, item 3' and 'warning' severity are all defensible and consistent with the source.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Q1 item 3 states 'Any conclusions articulated in a source publication should align with the prespecified hypothesis or research question from the described study or analysis'; the rule text ('FDA recommends') and title ('should align') keep it as a recommendation.
- The quote is the full sentence; its second element ('be supported by the results') is not claimed by this rule, which stays atomic on hypothesis alignment.
- Judgment is correct: comparing conclusions to a prespecified hypothesis requires scientific interpretation.
- applies_when, severity warning, and locator are appropriate.

Nearby rules

US-SUB-017