Firm-generated presentation should be limited to scientific information from its source publication(s)

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

Rule

A firm-generated presentation included in an SIUU communication should be limited to the scientific information on unapproved use(s) from one or more source publications.

Check

Confirm the presentation's scientific content and claims about the unapproved use come from the cited source publication(s). Do not count the recommended Q2 disclosures, the statement of which portions are firm-generated, or accurate presentational elements used to explain or illustrate the scientific content as violations. A violation is scientific information or claims about the unapproved use that do not come from the cited source publication(s).

Escalate when

Whether content strays beyond the source publication's scientific information, versus being an accurate explanatory presentational element, 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

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
- Supported: the quote is a complete sentence from Q5 and both halves of the rule appear in it.
- Not overstated - 'should' is retained and no binding force is claimed.
- Not atomic: the sentence carries two requirements that fail independently and have different remedies - (1) the firm-generated presentation is limited to the scientific information on unapproved use(s) drawn from the source publication(s), and (2) those source publication(s) are themselves consistent with the Q1 and Q4 recommendations. A presentation can stay strictly within a non-qualifying source, or stray beyond a perfectly qualifying one. The rule's own check states both findings separately.
- The rule text glosses Q1 as '(scientifically sound)' and Q4 as '(source-type-specific)'. Neither Q1 nor Q4's characterization is established by the quote, and Q1 is not in the source text supplied with this packet, so these parentheticals are unverified additions.
- 'judgment' is correct for whether the presentation's content strays beyond the source publication; applies_when, the Q5 locator and 'warning' severity are appropriate.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Q5 states 'The firm-generated presentation should be limited to the scientific information on unapproved use(s) from one or more source publications'; the rule text says 'should', but the title says 'must be limited', overstating a recommendation.
- The quote is a whole sentence; its second clause (source publications consistent with Q1 and Q4) is a separate recommendation, but quoting the full sentence is acceptable.
- The check is broader than the source: it calls 'anything beyond the scientific information contained in the cited source publication(s)' a violation, yet the same section recommends that firm-generated presentations include the Q2 disclosures and a statement identifying firm-generated portions (e.g., 'This presentation was developed by FIRM X.'), and permits presentational elements that accurately explain the content. As written, the check would flag recommended content.
- Judgment is correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Section V, Q5 states verbatim that 'The firm-generated presentation should be limited to the scientific information on unapproved use(s) from one or more source publications'; the rule restates this with 'should', matching the guidance's non-binding force.
- The quote is a whole sentence; its second clause (source publications consistent with Q1/Q4) is not folded into the rule, so the rule stays atomic.
- The check's carve-outs (Q2 disclosures, the firm-generated disclosure statement, presentational elements) track the same Q5 passage, which separately recommends those disclosures and Q3 presentational consistency, so they do not widen the rule.
- Judgment is correct: deciding whether content strays beyond the source publication is not a literal match. applies_when (HCP, SIUU) matches the guidance's scope; warning severity is defensible for guidance; locator Section V, Q5 is right.

Nearby rules

US-DISC-012 US-DISC-013 US-DISC-014 US-DISC-015 US-SCI-033 US-SCI-034 US-SCI-035 US-SCI-038