Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers." This guidance describes FDA's enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm's approved/ cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients. This guidance finalizes the revised draft guidance of the same title issued in October 2023. The October 2023 revised draft guidance revised and replaced the draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices," issued in March 2014, which itself revised the final guidance entitled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices," issued in January 2009. This guidance is not for current implementation, pending the Office of Management and Budget's (OMB's) decision on the collection of information.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.