Adverse Event Data In Labeling Should Be Updated More Frequently, FDA Says
FDA is emphasizing that sponsors should make more of an effort to continuously update the adverse events sections of their products' labeling
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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"...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials