Disclose an applicable REMS and its goals

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

Rule

If a REMS has been established for the medical product, the SIUU communication's risk statement should disclose that fact and describe the REMS's goal(s).

Check

Determine whether a REMS exists for the product; if so, confirm the communication discloses its existence and states its goal(s). A violation is an existing REMS that goes unmentioned or whose goals are not described.

Where this comes from

Section V, Q2 · page 19. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…DA-required labeling (or a mechanism for obtaining this labeling, as appropriate) A statement describing any contraindication(s) in the FDA-required labeling for the medical product A statement describing any serious, life-threatening, or fatal risks posed by the medical product that are in the FDA-required labeling for the medical product or known by the firm and that are relevant to the unapproved use(s) If a risk evaluation and mitigation strategy (REMS) has been established under 21 U.S.C. 355-1, the statement should disclose that fact and should describe the goal(s) of the REMS A statement identifying any authors, editors, or other contributors to publication(s) included in the SIUU communication who were employees of or consultants to or who received compensation from the firm at the time of writing, editing, or contributing to the publication, to the extent a firm acting reasonably would know of such relationship In the case of an SIUU communication that includes one or more source…

Open the original at page 19 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 a complete conditional sentence from the Q2 list verbatim, and the rule restates it without strengthening: the disclosure is triggered only if a REMS has been established.
- Not overstated: 'should disclose' and 'should describe' track the source's own wording inside the recommended-disclosure list.
- Atomic: the source states the REMS disclosure as one item — disclose the fact and describe the goals — and both parts are triggered by the same single condition. Splitting them would depart from the source without adding reviewer value.
- Determinism 'deterministic' is right: whether a REMS exists is a matter of record, and whether the communication states that fact and the REMS goal(s) is presence or absence.
- Authority 'guidance' is correct and is not overclaimed. The citation to 21 U.S.C. 355-1 in the quote only identifies what a REMS is; the disclosure recommendation itself is FDA's, so this does not 'belong to' the statute.
- applies_when matches the Q2 SIUU-to-HCP scope.
- Severity 'warning' is defensible and consistent with the other Q2 disclosure rules.
- Violable: an SIUU communication for a REMS product can omit the REMS or its goals.

Nearby rules

US-DISC-005 US-DISC-006 US-DISC-007 US-DISC-008 US-DISC-009 US-IND-014 US-RISK-024 US-RISK-025 US-RISK-026 US-RISK-027 US-SUB-016