Your questions, comments and input will help FDA advance pediatric regulatory science.
FDA has access to a large database of trial data from over 1,600 pediatric clinical trials and related trials in adults.
DPMH seeks from external stakeholders research questions with potential to accelerate or inform pediatric drug development that can be addressed using data submitted to the FDA.
The FDA is interested in:
1. What research question(s) should FDA staff investigate using pooled analyses of pediatric clinical trial data to advance pediatric drug development?
2. Why is/are these question(s) important and how will it/they advance pediatric drug development?
3. What types of data would be most valuable in answering your question?