The FDA issued draft guidance on assessing the safety of gene-edited products, focusing on next-generation sequencing-based approaches and bioinformatics methods to characterize risks such as off-target editing and loss of genome integrity. The document emphasizes nonclinical evaluation strategies for genetically engineered human products. For developers, the guidance changes the compliance target for how genomic risk is measured before clinical translation, especially where product-specific editing profiles are required. The move comes as regulators globally tighten expectations around genomic safety analytics for editing modalities, reinforcing the importance of sequencing readouts, computational interpretation, and traceable nonclinical evidence packages.