Asked. Answered. Now Move On: FDA Issues Guidance on Responding to Unsolicited Requests for Off-label Information about Prescription Drugs and Medical Devices

The Food and Drug Administration (FDA) recently issued a draft guidance entitled “Responding to Unsolicited Requests for Off-label Information about Prescription Drugs and edical Devices.” The guidance, while not legally binding, provides the agency’s current thinking on how companies should handle unsolicited requests for off-label information, whether in a public or private forum.2 Comments to the draft guidance may be submitted to the FDA within 90 days of publication in the Federal Register.

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