Genome edit­ing prod­ucts: FDA rec­om­mends at least 15 years of fol­low-up af­ter clin­i­cal tri­als

As In­tel­lia re­cent­ly un­veiled its lat­est promis­ing da­ta around one in a se­ries of po­ten­tial­ly game-chang­ing gene ther­a­pies, the FDA on Tues­day sought to fur­ther en­cour­age the field with new draft guid­ance on what should be sub­mit­ted in a clin­i­cal tri­al ap­pli­ca­tion and what po­ten­tial­ly con­cern­ing safe­ty is­sues to track for these genome edit­ing prod­ucts.

The agency is up­front about the risks of genome edit­ing, as Al­lo­gene was hit with a clin­i­cal hold and pre­clin­i­cal stud­ies sug­gest po­ten­tial risks. The draft guid­ance points to sev­er­al spe­cif­ic risks as­so­ci­at­ed with genome edit­ing, in­clud­ing off-tar­get edit­ing, un­in­tend­ed con­se­quences of on- and off-tar­get edit­ing, and the un­known long-term ef­fects of on- and off-tar­get edit­ing.

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