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Business · 14/10/2010Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance for Early Clinical Trials with Live Biotherapeutic Products

Summary

The FDA has made available a draft document outlining recommendations for IND sponsors to submit INDs for early clinical trials involving live biotherapeutic products, as announced in September 2010.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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