Business · 10/01/1997Updated: 10/18/2026 · 1 min read

FDA Releases Guidance for Autologous Somatic Cell Therapy Products

Summary

The FDA has published a guidance document to help applicants prepare chemistry, manufacturing, and controls information and establishment descriptions for autologous somatic cell therapy products, which may aid in complying with federal regulations.

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

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