Correspondence to “Escape Velocity—The Launch of Microbiome Therapies” - Summary - MDSpire
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Response to “Escape Velocity—The Emergence of Microbiome-Based Therapies”

  • By

  • Bernat Olle

  • Ryan Ranallo

  • L Clifford McDonald

  • November 20, 2024

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Objective:

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.

Original Source(s)

Correspondence to “Escape Velocity—The Launch of Microbiome Therapies”

  • by Bernat Olle, Ryan Ranallo, L Clifford McDonald

  • November 20, 2024

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