The increasingly patient-centric approach to drug development and regulation may necessitate the development of separate product labeling for patients, one industry researcher believes.
Patient Experience Data May Require Separate Label, Genentech Suggests
US labeling for Genentech's Rituxan Hycela appears to have broken new ground with a 'Patient Experience' section describing summary data from a patient preference study; however, the company's global head of outcomes research says large volumes of patient-centric data would be difficult to reflect within the current labeling framework.
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