Include prominent statement of all important safety information, including any boxed warning

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

Rule

The response should include a prominent statement of all important safety information for the product, including any boxed warning if applicable.

Check

Check the response for a prominent, complete safety information statement, including boxed warning content where one exists for the product.

Escalate when

Completeness or prominence of the safety statement is debatable.

Where this comes from

Section V, Recommendation 6 (A prominent statement providing … bullet) · page 12. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

This rule is one item of a list. The list is introduced by: Information distributed in response to an unsolicited request should be accompanied by the following:

…ert 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 maintain the following records: \ The nature of the request for information, including the name, address, and affiliation of the r…

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 by Section V, Recommendation 6: a prominent statement providing all important safety information, including any boxed warning if applicable, should accompany the response.
- The quote is a bare bullet fragment with no subject or modality and does not state a requirement without the lead-in at lines 300-301.
- The rule text is faithful and preserves both 'should' and the 'if applicable' qualifier on the boxed warning; the safety statement and the boxed warning are one packaged disclosure in the source, so treating them as one rule is acceptable.
- Judgment is correct - both prominence and the completeness of 'all important safety information' are evaluative.
- Authority guidance, locator and severity are appropriate.
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 by the fourth bullet of Section V, Recommendation 6: 'A prominent statement providing all important safety information including, if applicable, any boxed warning for the product'. The rule keeps 'should'. The boxed warning is part of that same single statement, not a separate requirement, so the rule is atomic.
- The quote is only the list's lead-in, with the stray list number '6.', and does not contain the requirement.
- The rule is correctly marked judgment, because completeness and prominence are assessments.
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 with 'should'; the boxed warning is part of the single important-safety-information statement, so the rule is atomic.
- The quote is a bare list item ('A prominent statement providing all important safety information...') with no lead_in; the recommendation is only in the non-adjacent lead-in sentence.
- The title 'Include prominent statement of all important safety information, including any boxed warning' is a bare command for a guidance 'should'.
- Section V applies to private responses to non-public unsolicited off-label requests; the rule text does not carry that limit.
- Judgment is correct: completeness and prominence are assessments.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Quote plus lead_in from Section V, Recommendation 6 supports the recommendation that the response be accompanied by a prominent statement of all important safety information including any boxed warning. Rule body uses 'should' correctly.
- Judgment determinism is correct (completeness and prominence of safety information). The boxed warning is part of the same bullet's single statement, so the rule is atomic.
- The title 'Include prominent statement of all important safety information, including any boxed warning' is a bare command derived from a non-binding 'should'.