MLRagent
Rules/risk disclosure/US-RISK-023

Public response should include a mechanism to access current FDA-required labeling, if any

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

Rule

In addition to contact and disclosure information, a public response should include a mechanism (e.g., a link) giving readily accessible access to the product's current FDA-required labeling, if any.

Check

Check that the public response provides a working means to reach the current FDA-required labeling. Do not flag the absence of a labeling mechanism for products that have no FDA-required labeling.

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.

…tive 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 promotional information. For example, a public online response should include a direct link to the current FDA-required labeling, if any, but should not include links to any other information (e.g., product websites, product promotional materials, firm websites, third- party websites). Furthermore, the uniform resource locator (URL) or web address where viewers are…
Open the original at page 15 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)
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as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved
2026-09-21 from www.fda.gov
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FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.