2 min read
As mentioned in part one of this blog, while the development of cell and gene therapy (C>) 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...
3 min read
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...
2 min read
Cell and gene therapy (C>) 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...