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Labeling Rule Implementation Focuses On Subpopulations And Consistency

Executive Summary

Subpopulation data is a growing area of interest: FDA's new labeling initiative does not adequately address the inclusion of subpopulation data, Office of Medical Policy Director Robert Temple acknowledged during a recent workshop on implementation of the revised format sponsored by the Drug Information Association and FDA. "There's also interest in the major demographic and other subgroup differences," Temple noted. "How much to make of those is a somewhat delicate matter, but this is another area of growing interest and I don't think it's actually, I hate to say this, well covered in the guidance....I don't know if you noticed this, but if you read the [New England Journal of Medicine] today, almost every outcome study will have what I've learned to call a forest plot. That's one of these things that shows the hazard ratios on a wide variety of subgroups....They're actually starting to show up in labeling and we've never really said very much about what to do with those things. Everybody knows you can't treat a subset finding the same way as the original...and yet there's tremendous interest in looking at consistency across the sub-groups. So I think it's something that needs more discussion"...

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