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The FDA doesn't regulate off-label use per se, but does [well, try to] regulate the advertisements for off-label use. Basically manufacturers are not "allowed" to do the latter, even though clinicians can still prescribe off-label. As an FDA document explains: the modern Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations prohibit ...


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Considering today's assertion that FDA has now approved certain pharms, does it follow that these prescriptions are no longer "off-label", but rather are indicated uses? No. The president is not the FDA, and the president's statements about FDA actions are not FDA actions. The only official source of information about drug approvals is the FDA's list of ...


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