FDA Working To Make Subgroups Stand Out
This article was originally published in Pharmaceutical Approvals Monthly
Data will be presented on dedicated website as part of a new action plan to enhance demographic subgroup data collection in clinical trials.
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Stakeholders tell FDA it should force sponsors to recruit more diverse populations for its clinical trials by refusing to approve applications with inadequate data or expediting those with the necessary information.
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.
Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.