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Regulatory Considerations for AAV Gene Therapies
The regulatory framework surrounding AAV-based gene therapies has been modernized considerably, particularly in the last five years. In collaboration with Cell & Gene Therapy Insights and industry thought leaders working in the field, we have captured the main areas to place your focus in support of regulatory submissions for AAV gene therapies. Read this article to gain insights into:
- When to start thinking about regulatory considerations for gene therapies
- Regulatory guidance as to when to lock in your processes
- Potential areas of focus for future regulatory guidance
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