Source publication(s) for a firm-generated presentation must meet Q1 and Q4 recommendations

DisputedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

The source publication(s) underlying a firm-generated presentation should be consistent with the recommendations in Q1 and Q4 of this guidance.

Check

Check the source publication(s) underlying the firm-generated presentation against the Q1 and Q4 criteria. A violation is a firm-generated presentation built on source publication(s) that do not meet the Q1 and Q4 recommendations.

Escalate when

Whether a source publication meets the Q1 and Q4 criteria can require judgment.

Where this comes from

Section V, Q5 · page 28. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…t with the recommendations in this guidance, an SIUU communication that includes a firm-generated presentation should be truthful and non-misleading and should provide and appropriately present all information necessary for HCPs to understand and evaluate the strengths and weaknesses, validity, and clinical utility of the presented scientific information on unapproved use(s), as further explained in this section. The firm-generated presentation should be limited to the scientific information on unapproved use(s) from one or more source publications, and the source publication(s) should be consistent with the recommendations in Q1 and Q4 of this guidance. Firms should provide the source publication(s) with the firm-generated presentation. Firms should include all information material to the representations made in the firm-generated presentation with those representations within the firm-generated presentation. For example, if a firm-generated presentation includes information about study results, the firm-generated presentation should include all material aspe…

Open the original at page 28 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 — reject
claude-code:opus · 2026-09-21
Reviewer's reasons
- The rule is only a cross-reference: 'consistent with the recommendations in Q1 and Q4' bundles every Q1 recommendation (scientifically sound studies, existing scientific knowledge, retraction, conclusions aligned with prespecified hypotheses) and every Q4 recommendation (reprint journal independence, editorial expertise, COI policy, peer review, availability, reference-text characteristics). These are independently checkable requirements, so it is not atomic, and a reviewer cannot apply it without applying those individual rules.
- Those requirements already exist as separate rules drawn from Q1 and Q4 (e.g., US-SCI-019, US-SCI-020, US-SCI-028, US-SCI-030, US-SCI-036, US-SCI-037, US-SUB-014, US-SUB-015), and because Q5 recommends that firms provide the source publication(s) with the firm-generated presentation, those source publications fall within the SIUU communications those rules already cover.
- The title also says 'must meet' for a 'should' recommendation.

Nearby rules

US-SCI-032 US-DISC-012 US-DISC-013 US-DISC-014 US-DISC-015 US-SCI-032 US-SCI-033 US-SCI-034 US-SCI-035