The US Food and Drug Administration (FDA) has revised draft guidance on the dissemination of information to health care providers (HCPs) regarding off-label uses of pharmaceuticals and medical devices.
In the guidance, which was published on 24 October 2023, FDA said it aims to “strike a careful balance between supporting HCP interest in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care of an individual patient, and mitigating the potential that the government interests advanced by these statutory requirements will be undermined.”
FDA prohibits sponsors from disseminating information on products’ unapproved uses, yet notes that “in certain circumstances, however, HCPs may be interested in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care of an individual patient.”…
