Firm-generated presentation itself should include Q2 disclosures

DisputedwarningFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

The firm-generated presentation itself, not only the SIUU communication it accompanies, should carry the disclosures recommended in Q2 of this guidance.

Check

Confirm the Q2 disclosures (see the individual Q2 disclosure rules, e.g. US-DISC-005, US-DISC-006, US-DISC-008, US-DISC-009, US-IND-014, and the other Q2 items) appear in the firm-generated presentation. A violation is a firm-generated presentation missing one or more Q2 disclosures.

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.

…he 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 aspects of and limitations related to the study design, methodology, and results necessary to interpret the presented information directly with the presented information. Firm-generated presentations should include the disclosures recommended in Q2 of this guidance and should also clearly disclose what portions of the SIUU communication are firm-generated. For example, a firm-generated presentation could include the following statement: "This presentation was developed by FIRM X." Firm-generated presentations should be consistent with the recommendations in this guidance regarding presentational considerations in Q3. Additionally, to ensure a firm-generated presentation is truthful and non-misleading, the firm-generated presentation should not, for example, do any…

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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence from Q5 and supports both halves of the rule: firm-generated presentations should include the Q2 disclosures and should clearly disclose what portions of the SIUU communication are firm-generated.
- Not atomic: these are two independently checkable requirements joined by 'and should also' in the source. A piece can carry the full Q2 disclosure set and still fail to identify firm-generated portions, and vice versa; a reviewer would want separate findings.
- The title says 'must include' where the source says 'should include' — an obligation asserted from a non-binding guidance. The rule body correctly uses 'should'.
- Determinism 'deterministic' is defensible (presence of the Q2 disclosures and of a firm-attribution statement such as 'This presentation was developed by FIRM X'). Severity 'warning', authority 'guidance' and the Q5 locator are correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Section V Q5 states: 'Firm-generated presentations should include the disclosures recommended in Q2 of this guidance and should also clearly disclose what portions of the SIUU communication are firm-generated.' The rule correctly takes only the first clause. The second clause is US-DISC-014.
- The rule is not atomic. 'The disclosures recommended in Q2' is a list of about ten independently checkable items: the not-approved statement, approved uses, labeling limitations, a copy of the labeling, contraindications, serious risks and REMS, contributor relationships, study aspects, study limitations, conflicting conclusions, and publication date. A single pass/fail on 'the Q2 disclosures' cannot be applied consistently. Most of these items already have their own rules (for example US-DISC-005 to -009 and US-IND-014).
- The Check says the disclosures should appear 'in or with the firm-generated presentation'. The source says the presentations 'should include' them, which means in the presentation itself. 'or with' loosens the recommendation, and the fact that the presentation itself should carry them is the only thing this rule adds beyond the Q2 rules.
- Recommendation language is kept. Presence of each disclosure is deterministic. Scope, severity and the locator 'Section V, Q5' are correct.
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 a complete Q5 sentence. The rule addresses only its first clause (Q2 disclosures in the firm-generated presentation). That is an acceptable atomic split, and the rule and title keep 'should'.
- The determinism is wrong. The Q2 disclosures this rule incorporates include items that need judgment, such as 'all material limitations' and conflicting conclusions from 'scientifically sound' studies, and whether contributor relationships are ones 'a firm acting reasonably would know'. Presence of the set cannot be settled by literal match, so it should be judgment.
- The check text lists internal rule IDs (US-DISC-005, US-DISC-006, and so on) and ends with the vague 'and the other Q2 items'. This is pipeline cross-referencing, not a check a reviewer can apply from the rule alone.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a whole sentence from Q5, and it supports the rule that firm-generated presentations should include the Q2 disclosures. The rule uses 'should' and takes only the first clause. The second clause (clearly disclose which portions are firm-generated) is left out, so the rule stays atomic.
- The Check text contains internal pipeline rule IDs (US-DISC-005, US-DISC-006, US-DISC-008, US-DISC-009, US-IND-014). Rule and check text must not reference internal IDs.
- The rule statement says the presentation should carry the disclosures 'not only the SIUU communication it accompanies'. In the source, however, firm-generated presentations are included in the SIUU communication (they do not merely accompany it). The phrase adds a framing the source does not state.
- The rule is marked deterministic, but the Q2 disclosures it pulls in include judgment items: 'all material aspects' and 'all material limitations' of the study, conflicting conclusions from other scientifically sound studies, and risks 'relevant to the unapproved use(s)'. Confirming that all Q2 disclosures are present therefore takes judgment.

Nearby rules

US-DISC-013 US-DISC-014 US-DISC-015 US-SCI-032 US-SCI-033 US-SCI-034 US-SCI-035 US-SCI-038