Lexology January 21, 2025
The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance), which describes permitted dissemination of scientific information on unapproved uses (SIUU) of approved/cleared medical products by firms to healthcare providers (HCPs). In short, this guidance covers FDA policy regarding manufacturer dissemination of off-label information about approved/cleared medical products. The updated guidance finalizes FDA’s proposed approach from its 2023 draft guidance, with notable revisions in response to industry and public criticism of the draft. Below we summarize the key changes implemented in the final guidance and consider what questions remain outstanding under the agency’s revised approach.
Background
FDA has allowed...
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