Navigating the regulatory path of CRISPR-based therapeutics

12 May 2024

The translation of CRISPR therapies from research to clinical application requires not only technical progress but also careful adherence to regulatory guidelines and ongoing dialogue with regulatory authorities. Therapies targeting genetic or rare diseases often face prolonged development timelines, but engagement with the FDA's Expedited Programs can expedite the process. Recent indications from the FDA's Center for Biologics Evaluation and Research signal a growing inclination towards Accelerated Approval for gene therapies, emphasizing the agency's commitment to facilitating the availability of critical treatments for rare conditions. GenScript offers insights into navigating the complex regulatory landscape of cell and gene therapies, aiding stakeholders in optimizing their path to success.