Disclose the product's FDA-approved indication(s) prominently in the response

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

Rule

Information distributed in response to an unsolicited request should be accompanied by a prominent statement disclosing the indication(s) for which FDA has approved or cleared the product.

Check

Check for a prominent statement of the approved indication(s) accompanying the response; flag if missing or inconspicuous.

Escalate when

Whether the disclosure is sufficiently prominent is debatable.

Where this comes from

Section V, Recommendation 6 (A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product bullet) · page 12. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…llowing: \ A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet) \ A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided \ A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product \ A prominent statement providing all important safety information including, if applicable, any boxed warning for the product \ A complete list of references for all of the information disseminated in the response (e.g., a bibliography of publications in peer-reviewed medical journals or in medical or scientific texts; citations for data on file, for summary documents, or for abstracts) 7. A firm should mai…

Open the original at page 12 on fda.gov ↗Read our full copy →

Document: FDA guidance: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (see document)
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: 8ab6bfda34ad39a70987805b…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Basisunsolicited-request

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 substance is supported: Section V, Recommendation 6 lists 'A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product' among the items that should accompany a response.
- The quote as captured is a bare noun phrase lifted from a bullet list. Standing alone it has no subject and no modality - it does not state that anything should be done - so it misrepresents the source as quoted and cannot be read as establishing the rule without the list lead-in at lines 300-301.
- Judgment is correct because the requirement turns on prominence.
- Authority guidance and severity warning are appropriate; scope to responses to unsolicited requests matches Section V.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The substance is supported. The third bullet of Section V, Recommendation 6 reads 'A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product', and the rule text keeps 'should' and 'prominent'.
- The quote is defective. It is only the lead-in line of the list, begins with the stray list number '6.', and contains none of the text about indications. As quoted, it would support any of the five list items equally.
- The judgment determinism is correct because prominence is an impression call. The rule is atomic because it covers only the indication statement, not the other four bullets.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The rule text faithfully restates the fourth bullet of Section V Recommendation 6 using 'should'.
- The quote is a bare list item ('A prominent statement disclosing the indication(s)...') with no lead_in; read alone it has no subject or modal, and the recommendation ('should be accompanied by the following') is only in the non-adjacent lead-in sentence.
- The title 'Disclose the product's FDA-approved indication(s) prominently in the response' converts a guidance 'should' into a bare command.
- Section V applies to private responses to non-public unsolicited off-label requests; the rule text does not carry that limit.
- Judgment determinism is right because prominence is an impression.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Section V, Recommendation 6 of the (draft) guidance supports the substance: information distributed in response to an unsolicited request should be accompanied by a prominent statement disclosing the approved/cleared indication(s). Section VI confirms private follow-up to public requests follows Section V, so the unsolicited-request scope is justified.
- The quote is a bulleted list item with no subject or verb ('A prominent statement disclosing ...'); the rule carries no lead_in, unlike its sibling rules from the same list, so the quote alone does not show the recommendation it belongs to.
- The title 'Disclose the product's FDA-approved indication(s) prominently in the response' is a bare command; the source only says the information 'should be accompanied by' this statement (non-binding guidance). The rule body correctly uses 'should'.
- Judgment determinism is correct (prominence); warning severity is defensible for a guidance recommendation.