Blogs
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Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ
1/6/2025
The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.
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Unraveling The Complexity Of Cell Therapy: Advancements And Challenges
11/26/2024
Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.
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Navigating The Cell And Gene Regulatory Landscape
10/3/2024
Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.
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Pre-Launch Checklist - A Roadmap To Success
6/21/2024
The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.