FDA Unveils Draft Route to Speed Gene and Cell Therapies to Patients
The FDA issued a draft guidance showing how sponsors can reuse existing public data—such as CMC, nonclinical and clinical results—to streamline regulatory submissions for somatic genome-editing therapies, with the goal of accelerating access for patients with rare or life-threatening diseases while maintaining safety and efficacy; sponsors are encouraged to engage early (e.g., INTERACT) and submit comments within 90 days.