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 |
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 espaƱol) |
Mayo Clinic |
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 |