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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