Business · 10/04/2008Updated: 10/17/2026 · 1 min read
FDA Releases Guidance on Human Somatic Cell Therapy IND Applications
Summary
The FDA has made available a guidance document outlining recommendations for sponsors and instructions for reviewers on the content and review of Chemistry, Manufacturing, and Control (CMC) information for human somatic cell therapy Investigational New Drug Applications (INDs).
Original source language: Federal Register — Food and Drug AdministrationOpen original release →