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2 min read

Part Two: Key Takeaways for Successful Development of Cell and Gene Therapies

As mentioned in part one of this blog, while the development of cell and gene therapy (C&GT) products has accelerated in recent years, even the best therapeutic may not reach patients who need it if study design and execution are not done correctly. It...

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3 min read

Regulatory Guidance Monthly Review - July 2021

July 2021 

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical...

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2 min read

Part One: Key Takeaways for Successful Development of Cell and Gene Therapies

Cell and gene therapy (C&GT) products are beginning to deliver on their long-hoped-for promise. CAR-T technology has proven to be a powerful new weapon in cancer treatment, and FDA approval of Luxturna in 2017 demonstrated the potential of gene therapies...

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