The Sound Of Silence: FDA Ponders How To Label When No Subgroup Difference Found
This article was originally published in The Pink Sheet Daily
Clinical trial diversity meeting may broach the subject of whether drug labels should indicate that subgroup differences were explored, but none found.
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Extension of the Clinical Trial Engagement Network is aimed at increased diversity in clinical trials, which is becoming increasingly important as more drugs are targeted at specific groups.
FDA’s Bob Temple says “document” being drafted will instruct reviewers to pay more attention during sponsor meetings and eliminate unnecessary exclusions from protocols.
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