State the publication date of referenced source publications

DisputednoteFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

FDA recommends that, among the other recommended items, if the publication date of a referenced or included source publication is not already specified in the source publication or its citation, an SIUU communication state that date.

Check

Check whether the source publication or its citation already shows a publication date; if not, confirm the communication supplies one. A violation is a missing publication date nowhere stated.

Where this comes from

Section V, Q2 · page 20. 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: FDA recommends that firms include all of the following information as part of SIUU communications:

… other sources”). All material limitations related to the study design, methodology, and results. Any conclusions—from other scientifically sound studies that evaluated the same or similar hypotheses or research questions—that are in conflict with the conclusions from the studies or analyses described in the source publication(s). The citations for any such studies should also be included. The publication date of any referenced or included source publication (if not specified in the source publication or citation). Q3. What presentational considerations should firms take into account for SIUU communications? There are several presentational considerations that can help ensure that SIUU communications are conveyed in a manner that enhances and does not interfere with HCP understanding and evaluation of the underlying scientific information, including its limitations. To that end, FDA recommends the following: 1. SIUU comm…

Open the original at page 20 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

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
- Supported: the final Q2 list item is 'The publication date of any referenced or included source publication (if not specified in the source publication or citation).' The rule reproduces both the requirement and its built-in exception accurately.
- The quote is a list item that drops the stem making it a recommendation ('FDA recommends that firms include all of the following information...'); as quoted it is a noun phrase, not a clause.
- Determinism 'deterministic' is correct: a publication date is present or absent, and the exception is likewise settled by inspection of the source publication or citation.
- Severity 'note' is defensible for a date disclosure, authority 'guidance' matches, and the Q2 locator and HCP / unapproved-use-scientific scoping are correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Section V Q2 lists 'The publication date of any referenced or included source publication (if not specified in the source publication or citation).' The rule states this faithfully, including the exception.
- The rule keeps 'FDA recommends'.
- Whether a date is present is a literal check, so 'deterministic' is correct. 'note' severity is defensible for a date disclosure. Scope and locator are correct.
- The rule's quote is only the list's lead-in sentence, which several rules share. The quote therefore does not contain the item that establishes this rule. The verifier contract now provides a `lead_in` field for a list item that is not adjacent to its lead-in, so the quote can and should be the item itself.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim the last Q2 list item. The rule body correctly keeps the condition 'if not specified in the source publication or citation' and frames it as a recommendation.
- A deterministic check is correct because the presence of a date settles it. A note severity is defensible.
- The quote is a bare list item. Its introducing sentence is far from it in the source, and there is no lead_in.
- The title 'State the publication date of referenced source publications' is a bare command and drops the condition.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim the last Q2 list item, under the correct lead_in. The rule statement keeps the 'if not specified in the source publication or citation' condition and says 'FDA recommends'.
- The title 'State the publication date of referenced source publications' is a bare command. It also drops the condition that applies only when the date is not already given.
- Deterministic is correct because a date is either present or absent. Severity 'note' is defensible.

Nearby rules

US-DISC-005 US-DISC-006 US-DISC-007 US-DISC-008 US-IND-014 US-RISK-024 US-RISK-025 US-RISK-026 US-RISK-027 US-RISK-028 US-SUB-016