The FDA released draft guidance on using next-generation sequencing and bioinformatics to assess the safety of genome-edited therapies, focusing on off-target edits and loss of genome integrity in human gene-edited products. The draft is designed to standardize nonclinical sequencing strategies used in IND submissions and in biologics license applications. The agency’s framework emphasizes how sponsors should incorporate sequencing plans that match both on- and off-target edit site analysis goals, with the draft noting scenarios where short-read strategies may be adequate for small edit windows. The FDA said final guidance would also support its broader efforts to accelerate individualized therapies for ultra-rare diseases. For developers, the guidance formalizes what evidence regulators expect for gene-editing risk characterization as more programs move from preclinical models into human trials.