Single Patient Drug Leaflet Logical, Complicated To Achieve - Woodcock
FDA officials are leaning toward a single document to inform patients about their medications, but whether and how that can be accomplished remain unanswered questions
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FDA is nearing completion of guidance on labeling for combined oral contraceptives with an eye toward improving communication with more visual presentations rather than relying on prose.
The single-page format could serve as a template as FDA tries to simplify patient information that accompanies prescription drugs.
FDA will look at which should come first – benefits or risks – when it studies patients' response to three one-page prototypes of patient medication information.