Source publications must describe scientifically sound studies

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

Rule

FDA recommends that firms only include source publications in an SIUU communication if the studies or analyses they describe are scientifically sound — meeting generally accepted design and methodological standards for the type of study, with limitations evaluated to determine reliability.

Check

Assess whether the underlying study/analysis meets generally accepted design and methodological standards for its type (e.g., prespecified hypothesis, bias controls). A violation is a source publication describing a study so flawed that even full disclosure of its limitations would not permit interpretation of its results.

Escalate when

The reviewer cannot determine from the study methodology section whether generally accepted design/statistical standards were met, or the study type is unfamiliar (e.g., novel real-world evidence design).

Where this comes from

Section V, Q1, item 1 · page 15. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…communications are firm-initiated communications directed to HCPs engaged in prescribing or administering medical products to individual patients, it is critical that the source publications that firms choose to share in their SIUU communications are not likely to lead to direct or indirect patient harm when HCPs rely upon the communication to inform clinical decisions. Accordingly, FDA recommends the following: 1. Source publications included by firms in SIUU communications should describe studies and analyses that are scientifically sound. To be scientifically sound, the studies or analyses should meet generally accepted design and other methodological standards for the particular type of study or analysis performed (e.g., provide a clear description of the prespecified hypothesis stated and tested, acknowledge and account for potential bias, and otherwise meet generally accepted scientific standards), taking into account established scientific pri…

Open the original at page 15 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 the complete first recommendation under Q1 ('Source publications included by firms in SIUU communications should describe studies and analyses that are scientifically sound.') and the rule statement keeps it in FDA's recommendation voice ('FDA recommends that firms only include...'), so it does not convert a non-binding recommendation into an obligation.
- The elaboration in the rule ('generally accepted design and methodological standards for the type of study, with limitations evaluated to determine reliability') tracks the two sentences that immediately follow the quote in Q1 item 1, and the check's violation threshold ('so flawed that even full disclosure of its limitations would not permit interpretation of its results') is taken from the source's own unreliability paragraph rather than invented.
- Judgment determinism is right: 'generally accepted design and other methodological standards' and evaluating a study 'in light of its limitations' turn on scientific assessment, not presence/absence.
- applies_when (HCP audience, unapproved-use-scientific basis) matches the guidance's stated scope — SIUU communications are firm-initiated communications directed to HCPs engaged in prescribing or administering the product — and is neither invented nor missing an obvious limit.
- Locator 'Section V, Q1, item 1' is correct; severity 'warning' is defensible for a recommendation whose breach is a scientific-quality failure rather than an omitted mandatory disclosure.
- The title uses 'must', which reads more strongly than the guidance voice, but the rule statement, check and authority field are all correctly non-binding, so this is a wording preference rather than a substantive overstatement.

Nearby rules

US-MIS-031