Firm-generated presentation should identify firm-generated portions

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

Rule

A firm-generated presentation should clearly disclose which portions of the SIUU communication were created by the firm.

Check

Confirm firm-generated content within the presentation is clearly labeled as such. A violation is a presentation that does not identify which portions are firm-generated.

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

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a whole sentence from Section V Q5. Its second clause, 'should also clearly disclose what portions of the SIUU communication are firm-generated', directly supports the rule, and the rule keeps 'should'.
- It is a single presence check. The source's example statement ('This presentation was developed by FIRM X.') shows it can be settled by the presence of a disclosure, so 'deterministic' is acceptable.
- Scope, severity and the locator 'Section V, Q5' are correct.

Nearby rules

US-DISC-012 US-DISC-012 US-DISC-013 US-DISC-015 US-SCI-032 US-SCI-033 US-SCI-034 US-SCI-035 US-SCI-038