Challenging Standardization Assumptions to Embrace Flexible Development Strategies & Improve FDA Engagement for Microbiome Products
- Addressing misconceptions around FDA regulatory expectations to demonstrate that flexible, product-specific approaches are preferred over rigid standardization frameworks for complex microbiome products
- Examining why standardizing assays and release specifications across highly variable live biotherapeutic products is impractical and how product-specific strategies accelerate development timelines
- Encouraging open sharing of assay approaches and development experiences across the industry to build collective knowledge and enable more practical regulatory strategies for diverse microbiome products