FDA Working To Make Subgroups Stand Out
This article was originally published in The Pink Sheet Daily
Data will be presented on dedicated website as part of a new action plan to enhance subgroup data collection in clinical trials.
You may also be interested in...
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.
Pink Sheet Podcast: Finally, A US FDA User Fee Deal, ‘Pandemic Is Over’ Take-Aways, Tpoxx Development Issues
Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.