Off label drug promotion – change may be coming soon

A few weeks ago, the Food and Drug Administration (FDA), released a report establishing a final rule amending regulatory definitions of what is considered “intended use” for drugs which had originally required drug companies to include labeling for unapproved uses the drug company knew about. The FDA revised this in January stating that if a drug company has plans to promote a drug off-label based on the “totality of the evidence” then similar labeling was required.

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