FDA Launches New Crowdsourcing Challenge to Solicit Input on Research Questions to Inform Pediatric Drug Development Today, the Division of Pediatrics and Maternal Health (DPMH) within FDA's Center for Drug Evaluation and Research (CDER) launched the "Send Your Pediatric Research Questions to FDA" crowdsourcing challenge. This challenge provides an opportunity for interested stakeholders to submit ideas for research using pooled analyses of pediatric clinical trial data directly to FDA's scientific staff. In recent years, FDA's scientists have published numerous pooled analyses that have advanced pediatric regulatory science. FDA's pooled pediatric analyses have deepened our understanding of extrapolation of adult efficacy data, investigated relationships between biomarkers and different clinical endpoints used in regulatory submissions, and explored the use of innovative trial designs in small populations. However, DPMH wants to hear your ideas for research questions with potential to accelerate or inform pediatric drug development that can be addressed with pooled analysis. After this challenge ends, all submitted ideas will be reviewed, and DPMH may select one or more questions for inclusion in future internal research projects led by FDA staff. Please note that individuals who submit research questions will not obtain access to data or collaborate in any new research studies initiated by FDA. Submissions to this challenge must be received by August 20, 2021. Visit DPMH's Crowdsourcing site for more information about how to submit your research idea to the challenge and to see examples of ideas that may be considered. All submissions and discussions on the site will be moderated by FDA staff. | 
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