CBER Guidances Cover Genome Editing, Patient Preference, April 2026

FDA's CBER published a compilation of 12 recently issued guidance documents spanning January through April 2026, covering topics including genome editing safety assessment using next-generation sequencing, voluntary patient preference information over the total product life cycle, pyrogen and endotoxins testing, biosimilar development, FDA Form 483 responses, individualized therapies targeting specific genetic conditions, computer software assurance for production and quality management systems, cybersecurity in medical devices, minimal residual disease endpoints for accelerated approval, Bayesian methodology in clinical trials, and clinical decision support software. Nine of the 12 entries are Draft Guidances open for comment; three are final Q&A documents.\n\nPharmaceutical, biologics, and medical device companies should review the full listing to identify guidance applicable to their development programs. Firms developing gene therapy products using genome editing should pay particular attention to the draft safety assessment guidance, as it may establish new regulatory expectations for NGS-based testing in human gene therapy products.