Developing a Gene Therapy Clinical Trial: Tips and Tricks
Developing a gene therapy trial has its challenges. The Food and Drug Administration (FDA) and the Recombinant DNA Advisory Committee (RAC) are two federal advisory committees that have to approve trials prior to execution. These committees have strict rules and regulations that need to be followed. Moreover, timing is a factor that needs to be factored in as well. The RAC has specific time frames for committee meetings, and due to heavy submission volumes, the FDA has specific timelines for application review. In this chapter, we will give an overview of the FDA and RAC as well as their requirements for Investigational New Drug (IND) submission.
Ethic Review Board
Food and Drug Administration
Independent Ethics Committee
Investigational New Drug
National Institutes of Health
Recombinant DNA Advisory Committee
Research Ethics Board
- 1.FDA. Available at: www.fda.gov.
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- 3.Pre-IND meeting. Available at: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm153222.pdf.
- 4.National Institution of Health, Office of Science Policy: RAC. Available at: http://osp.od.nih.gov/office-biotechnology-activities/biomedical-technology-assessment/hgt/rac.
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