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| FDA Gene Therapy Guidances |
| FDA CBER Cellular & Gene Therapy Guidances Website |
Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) |
| Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) |
FDA CBER |
| Preclinical Assessment of Investigational Cellular and Gene Therapy Products |
FDA CBER |
| Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products |
FDA CBER |
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| Patient-Friendly Resources on Gene Therapy |
| Gene Therapy: Your Questions Answered |
National Organization for Rare Disorders (NORD) |
| A Guide to Gene Therapy |
Global Genes |
| Gene Therapy Inside Out |
FDA |
| Gene Therapy Educational Resources |
Genetic Science Learning Center |
| Gene Therapy Patient Education Webinars |
American Society for Gene and Cell Therapy (ASGCT) and NORD |
| Genoterapia (en español) |
Mayo Clinic |
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| Standards and Best Practices for New Programs |
| Regenerative Medicine Standards Landscape |
Standards Coordinating Body |
| Perspectives on Best Practices for Gene Therapy Programs |
Human Gene Therapy |
