Rely on published peer-reviewed or independent-source data to the greatest extent possible

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

Rule

FDA recommends that a firm rely, to the greatest extent possible, on published peer-reviewed journal articles, medical texts, or data from independent sources when substantiating an off-label response.

Check

Check the evidence base cited in the response for reliance on unpublished, non-peer-reviewed, or firm-generated data where published peer-reviewed or independent sources were available.

Escalate when

It is unclear whether independent, peer-reviewed sources existed and were reasonably available instead of the sources actually used.

Where this comes from

Section V, Recommendation 3 · page 11. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… at issue. The response should include complete copies of scientific reprints, technical literature, or other scientific and medical information responsive to the request, not just summary documents or abstracts prepared by the firm. The response can include unpublished data on file if they are responsive to the specific request (either supporting or casting doubt on the safety or efficacy of the off-label use). However, to the greatest extent possible, a firm should rely on published peer-reviewed journal articles, medical texts, or data derived from independent sources. To the extent the response consists of published reprints from journals, those reprints should be from journals that have a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors, contributors, or editors associated with the journal or organization. 4. Information distributed in response to an unsolicited request should be scientific i…

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
- The quote is a complete sentence (lines 272-273) and the rule restates it faithfully, preserving both the hedge 'to the greatest extent possible' and the recommendatory 'FDA recommends that a firm rely'.
- It does not overstate: the surrounding text expressly permits unpublished data on file when responsive, and the rule does not forbid such data — it states only the preference for published peer-reviewed, medical-text or independent-source data.
- Determinism 'judgment' is correct: 'to the greatest extent possible' turns on whether independent sources were reasonably available, which no literal match settles; the escalation clause states exactly that.
- One requirement; severity 'note' fits a preference rather than a disclosure failure; authority 'guidance' matches; locator (Section V, Recommendation 3) is correct — the sentence sits in the discussion under recommendation 3.
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 a complete sentence from the Recommendation 3 discussion. Its opening 'However' is set against the preceding permission to include responsive unpublished data on file, and the rule keeps the 'to the greatest extent possible' qualifier, so it does not turn the preference into a ban on unpublished data.
- The rule uses 'FDA recommends', which matches the guidance's authority. Weighing whether better sources were available is a judgment call, and severity 'note' fits a best-effort preference.
- The locator is correct.

Nearby rules

US-FB-011 US-MIS-026 US-SUB-010