Public response should include specific medical/scientific contact information

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

Rule

The public response should provide specific contact information (e.g., email address, telephone number, fax) for medical or scientific personnel/department so the requestor can follow up privately.

Check

Check that concrete contact details for medical/scientific personnel are present in the public response, not just a generic statement.

Where this comes from

Section VI, Recommendation 2 · page 14. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…should be limited to providing the firm’s contact information and should not include any off-label information. \ The firm’s public response should convey that the question pertains to an unapproved or uncleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information. \ The firm’s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication. After an individual has privately contacted a firm for more information regarding an off-label use of the firm’s product, the firm should provide a detailed response and maintain records following the parameters outlined in Section V of this draft guidance. Therefore, any substantive communication about off-label uses for the product, in response to the original unsolicited off- label question, should occur sol…

Open the original at page 14 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 the complete second bullet of Section VI Recommendation 2 (lines 400-403) and states exactly what the rule states: the firm's public response should provide specific contact information (e-mail, telephone, facsimile) for the medical or scientific personnel or department so the individual can follow up non-publicly.
- The rule keeps the guidance's recommendatory force ('should provide') and does not convert it into an obligation; authority 'guidance' matches the draft guidance it is drawn from.
- The guidance limit that this applies only to the *public* response to a *public* unsolicited request is carried in the rule title and rule text ('The public response should provide...'), which is acceptable where the scoping vocabulary (basis: unsolicited-request) cannot express it.
- Determinism 'deterministic' is defensible: the check is the presence of concrete contact details (an address, number or department contact) in the public response, which presence/absence settles.
- Single requirement; severity 'warning' is defensible for a disclosure-of-contact-route recommendation; locator (Section VI, Recommendation 2) is correct.
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 a complete Section VI Recommendation 2 bullet with its own subject, and the rule body correctly uses 'should'.
- The title says 'Public response must include specific medical/scientific contact information'. The source says 'should', and the document is non-binding guidance, so the title turns a recommendation into an obligation.
- Whether specific contact details (email, phone, fax) are present can be settled by a literal presence check, so 'deterministic' is acceptable. The locator is correct.
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 second bullet of Section VI Recommendation 2; it is a self-contained sentence with its own subject and 'should', so no lead_in is needed.
- The title and rule text keep 'should' and the limit to public responses.
- Deterministic is correct: presence of specific medical/scientific contact details settles it.
- Not a duplicate of any other rule in this packet.

Nearby rules

US-SCI-008 US-SCI-010 US-SCI-039