Paul Carlson
Seminars
Wednesday 25th June 2025
Regulatory Considerations for Microbiome-Based Therapeutics
8:30 am
- Interpreting the latest FDA guidance on LBPs, FMT-based therapies, and the shifting regulatory framework for microbiome drugs
- Addressing key hurdles in clinical trial design, potency validation, and manufacturing standards to meet FDA expectations
- Preparing for future regulatory trends with insights on accelerated approval pathways, real-world data integration, and evolving safety requirements
