To address the terminology used by the FDA regarding live biotherapeutic products (LBPs) and fecal microbiota products, emphasizing the need for consistent terminology for regulatory compliance.
Key Findings:
FDA refers to approved products as fecal microbiota products, not LBPs.
Fecal microbiota products have variable strain compositions.
Inconsistent use of terminology in academic and industry publications may hinder progress.
Interpretation:
The FDA's terminology indicates a preference for defined composition in LBPs, which is not reflected in current literature, potentially impacting product development and regulatory processes.
Limitations:
Previous publications, including the authors', used LBPs inconsistently with FDA terminology, which may affect future research and regulatory approval.
Conclusion:
Aligning terminology with FDA standards is essential for advancing microbiome therapy development.
