Disclose relevant risk information beyond the narrow scope of the request when material

AI-verifiedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

Even though a response should be tailored to the specific question asked, the firm should still include known or suspected risk information from other diseases or conditions if that risk information is relevant to the requested use.

Check

Check whether risk information bearing on the requested use, even if drawn from a different disease/condition context, was omitted from the response.

Escalate when

It is unclear whether risk data from another condition is relevant enough to the requested use to require inclusion.

Where this comes from

Section V, Recommendation 2 (exception) · page 11. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…e use of a drug or device for one particular disease or condition that is considered off-label for that drug or device (e.g., use of Drug X during pregnancy in patients with diabetes). Generally, a firm should provide information pertaining only to that disease or condition (i.e., the firm should provide a response tailored only to the use of Drug X during pregnancy in patients with diabetes). However, if there is information about known or suspected risks associated with other diseases or conditions that is also relevant to the disease or condition for which information was requested, the firm should provide such information to ensure a complete and accurate presentation of the risk issues associated with the requested use (e.g., Drug X is known to cause fetal harm when used in pregnant patients with arthritis, and this risk information should be disclosed as part of the response about use of Drug X during pregnancy in patients with diabetes). 3. Information distributed in response to an unsolicited request should be truthful, non- misleading, accurate, and balanced. A response should provide non-biased information or data relating to the particular off-label use that is the subject of the request, including applicable data that are not supportive or that cast doubt on the safety or efficacy of that use. For example, when conclusions of articles or t…

Open the original at page 11 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

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
- Directly supported by lines 253-258: if there is known or suspected risk information associated with other diseases or conditions that is also relevant to the condition asked about, the firm should provide it to ensure a complete and accurate presentation of the risk issues.
- The rule preserves the source's 'should' and its relevance condition, and correctly frames itself as the carve-out to the tailoring recommendation rather than as a free-standing duty to volunteer all risk data.
- One requirement - include relevant cross-condition risk information. Atomic.
- Judgment is correct: whether risk data from another condition is 'relevant' to the requested use is an evaluative call, as the escalate-when recognises.
- It is violable (a response can omit such risk information), the locator names the exception within Section V Recommendation 2, warning severity is defensible, and the quote is a complete sentence with its conditional intact.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the complete sentence that follows Example 12 in Section V, Recommendation 2, including its own e.g. Its subject ('the firm') is present, and 'However' only links it to the tailoring principle, which the rule text explains.
- The rule keeps 'should', and its trigger (risks from other diseases or conditions that are also relevant to the requested use) matches the source.
- The rule is correctly marked judgment, because relevance is an assessment. The escalation condition fits. The rule is atomic. The locator's '(exception)' label accurately describes where the sentence sits.