This presentation will provide an overview of regulatory considerations for microbiome-based product development in pediatric populations. Scientific and ethical issues for microbiome product development will be discussed in the context of relevant regulatory guidances. Pediatric Research Equity Act (PREA) requirements, 21 CFR Subpart D (Additional Safeguards for Children), and informed consent for this population will be highlighted. Important resources to consider when including pediatric populations in microbiome trials will be provided.
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