Tracking gene therapies
FDA's policies on long-term follow-up of participants in gene therapy trials involving retroviral vectors are unrealistic and should be replaced with a much less intensive set of requirements, members of the agency's Biological Response Modifiers Advisory Committee said on Friday.
The consensus of BRMAC members was that follow-up observation of gene therapy trial participants extending more than five years should be conducted or supported by government or a non-profit organization and should not be the responsibility of trial sponsors.
The committee did suggest that the categories of vectors requiring long-term follow-up should be expanded. It also provided guidance on the need to sequence viral vectors prior to Phase I trials and how FDA should respond to reports about the detection of gene therapy vectors in semen.
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