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Results The results (see Figs

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FDA routinely conducts similar, web-based inspections, which are well suited to reveal a products intended use often the determining factor in whether a product is a drug. See 21 CFR 201.128 (intended use can be derived from a broad array of objective factors, including labeling claims, advertising matter, or oral or written statements.) See also 21 USC 321(g) (defining drug based on, inter alia, its intended use)

However, as the definition of IC/BPS appears to be expanding from a bladder disease to a chronic pain syndrome, reliable new outcome measures will have to be developed