Which regulatory challenge is commonly associated with clinical application of gene therapy?
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Correct answer: Need for long-term safety monitoring over years
Because gene therapy can permanently change cells, long-term follow-up is needed to detect delayed adverse effects such as insertional mutagenesis or immunogenicity, making post-treatment surveillance critical.
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More Gene therapy basics questions
- Which of the following best describes why a “perfect vector” for gene therapy does not yet exist?
- How can gene therapy address diseases caused by a dominant negative mutation (where a mutant gene product interferes with normal function)?
- Which statement about non-viral gene delivery systems is correct compared to viral vectors?
- Which gene therapy approach could potentially treat a recessive loss-of-function genetic disease by restoring missing protein function?
- Which of the following is an advantage of using in vivo gene therapy over ex vivo gene therapy?
- Why is immune response a major concern in gene therapy using viral vectors?