Business · 31/03/2015Updated: 10/17/2026 · 1 min read

FDA Requests Additional Comments on Live Biotherapeutic Products in Early Clinical Trials

Summary

The FDA is seeking more input on the chemistry, manufacturing, and control information required for investigational new drugs containing live biotherapeutic products, which are used in early phase clinical trials, particularly when these products are derived from food or dietary supplements.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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