The U.S. Food and Drug Administration (FDA) recently finalized its 2023 draft guidance to industry on certain firm-initiated communications of scientific information on unapproved use(s) (SIUU) of medical products to health care providers (HCPs).
The guidance is titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” Importantly, this guidance applies only to communications about an “unapproved use of an approved product.” It does not cover statements about products that have not been approved. In common terms, “pre-approval promotion.”
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