What Guidance for Human Gene Therapy Investigational New Drug Applications (INDs): CMC, Preclinical, and Clinical Considerations requires
This FDA guidance outlines chemistry, manufacturing, and controls (CMC), preclinical, and clinical requirements for gene therapy INDs under 21 CFR Part 312. It applies to sponsors developing human gene therapy products and mandates detailed characterization, safety testing, and long-term follow-up per Section III-V of the guidance.
Pillar: Biotech & Genomics · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.1 · Last updated:
Primary source: https://www.fda.gov/media/113768/download
SHA-256 integrity: 2233bae52143c03f8f786602d0d0817ec7fb3d1d9a5e8b45c917cd75463c3f44
Primary Citations — 5 traced to source
- FDA Guidance for Human Gene Therapy INDs (2020), Section III.A - Vector Design and Construction
- FDA Guidance for Human Gene Therapy INDs (2020), Section III.C.4 - Testing for Replication Competent Virus
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