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Additionally, EURneffy could alleviate the risk of accidental needle-related sideeffects (such as injection into the blood vessel and hand) 3 and it has the attributes of being smaller in size, has better temperature sensitivity, and is less complex to use compared to needle-based injectors. 2007; 2(1):5-11. 2022 ; 17(11).
Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. For cell and gene therapy, a “big issue” she stated, was the complexity of manufacturing.
Yes there has been some slowing in the approval of drugs from the FDA, in part due to legitimate concerns in relation to drug safety. In terms of concerns over safety, it has meant that the FDA has been essentially very cautious in moving forward. Some of that funding is going towards other efforts, including food safety.
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