Business · 29/11/2012Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance for Preclinical Assessment of Cellular and Gene Therapy Products

The FDA has made available a draft document outlining recommendations for preclinical studies of investigational cellular and gene therapy products, aiming to clarify current expectations for supporting clinical trials

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

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