“…As patient experience data become more important, a ‘huge question that’s going to require a lot of discussion’ is whether there is a ‘role for revisiting what the label looks like and if there’s a section that would allow us more flexibility,’ said FDA’s Paul Kluetz. However, the agency recognizes that drug labeling is a limited communication vehicle for patient experience data, Kluetz said. ‘We’re working on other ways, forward-facing ways, to do so.’” Paid Subscription required to read more. (Source: Cathy Kelly, Pink Sheet, 5/9/17)
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