Business · 19/02/2019Updated: 10/17/2026 · 1 min read

FDA Announces Final Guidance for Expedited Development of Regenerative Medicine Therapies for Serious Conditions

Summary

The FDA has released a final guidance document outlining expedited development and review procedures for regenerative medicine therapies intended to treat serious or life-threatening diseases, providing industry sponsors with recommendations and interactions with the CBER review staff.

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

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