What is the primary regulatory distinction between a drug product's 'indication' and its 'intended use' in labeling?
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A
Indication refers to the disease state targeted; intended use encompasses the broader population and clinical setting described in labeling
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B
Intended use applies only to devices, not drugs
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C
Indication is determined by the manufacturer, while intended use is set exclusively by FDA
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D
They are legally interchangeable terms under 21 CFR