Public responses should not be promotional in nature or tone

Where this comes from

Section VI, Recommendation 4 · page 15. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ends that a representative who responds to a public request clearly disclose in his/her public response that he/she is a particular firm’s representative and inform the requestor of the name of the firm representative or department to contact should the individual choose to follow up directly with the firm in a non-public forum for detailed information about the unsolicited request for off-label information. 4. Public responses to public unsolicited requests for off-label information described in numbers 2 and 3 should not be promotional in nature or tone. In addition to a firm’s contact and disclosure information, a public response should include a mechanism for providing readily accessible current FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet). The public response should not provide any promo…

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.