Firm-generated presentation must be provided together with the source publication

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

Rule

Firms should provide the underlying source publication(s) along with any firm-generated presentation.

Check

Confirm the source publication(s) accompanies the presentation (hard copy with hard copy, or an electronic copy/direct link for electronic delivery). A violation is a firm-generated presentation delivered without the underlying source publication(s).

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.

…aluate 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 aspects of and limitations related to the study design, methodology, and results necessary t…

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 complete sentence in Q5 ('Firms should provide the source publication(s) with the firm-generated presentation.') and states the rule exactly.
- Not overstated: the rule reproduces the guidance's 'should' and adds nothing about consequences or binding force.
- Atomic: one delivery requirement, one finding.
- 'deterministic' is correct - whether the source publication(s) accompany the presentation is settled by presence or absence.
- Violable, and applies_when, the Q5 locator and 'warning' severity are all defensible. The check's parenthetical about hard copy versus an electronic copy or link is illustrative of how accompaniment is satisfied rather than an added requirement, so it does not misstate the source.

Nearby rules

US-DISC-012 US-DISC-013 US-DISC-014 US-DISC-015 US-SCI-032 US-SCI-034 US-SCI-035 US-SCI-038