The FDA issued draft gene-editing safety guidance for human gene therapy products, focusing on how sponsors should use next-generation sequencing and bioinformatics to evaluate off-target risks and chromosomal integrity before initiating or advancing edited therapies. The regulator outlined how nonclinical studies incorporating sequencing strategies would support investigational new drug submissions and biologics license applications. In parallel, the FDA also renewed attention on clinical trial results reporting. New enforcement-oriented reminders were sent to more than 2,200 sponsors and researchers tied to thousands of trials that have not disclosed results as required on ClinicalTrials.gov. Together, the actions tighten both scientific evidence expectations for genome editing and operational accountability for trial transparency.