The long-overlooked safety issue weighing on the FDA’s mind on day 1 of marathon gene therapy meeting
As the FDA closed out day 1 of its marathon gene therapy hearing, the agency gave an unusual glimpse into their conversations — and conflict — with companies trying to start gene therapy trials.
Routinely, FDA official Andrew Byrnes explained in the only followup question regulators asked during the 8-hour session, the agency has been forced to grapple with an impurity known as empty capsids — a long known but little discussed potential safety issue for gene therapies — and, crucially, how much to push back on companies who refuse to remove them because of how costly or time consuming it might be.
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