www.fdanews.com/articles/180179-fda-outlines-examples-of-communications-consistent-with-approved-labeling
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FDA Outlines Examples of Communications Consistent with Approved Labeling
January 23, 2017
The FDA is providing industry with a list of examples of product communications, including promotional materials, consistent with agency-approved labeling.
Sponsors can disclose information on the safety and efficacy profile of a drug, including comparative and pivotal clinical trial data, to provide context consistent with FDA-required labeling. Information on adverse reactions, a drug’s effect in a subpopulation and the long-term safety and efficacy of a product are also considered appropriate disclosures.
The FDA said sponsors cannot convey information about unapproved uses. For example, a drugmaker should not characterize a therapy as a monotherapy if it is only approved for use in combination with another treatment.