US FDA wants more informative labeling on certain medicines

The U.S. Food and Drug Administration has issued a draft guidance to provide recommendations for consideration when drafting the Indications and Usage section of human drug and biological product labeling. The FDA regulations require the Indications and Usage section of drug labeling to state that the drug is indicated for the treatment, prevention, mitigation, cure or diagnosis of a disease or condition, or for the relief of the disease or condition’s symptoms. This guidance provides recommendations for drafting the Indications and Usage section of the labeling, including a discussion of the scope of an indication and the inclusion of age groups in indications (US FDA, 6 July 2018).
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