CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed. Individualized gene therapy approvals at the US Food and Drug Administration (FDA) could speed up using a 510(k)-like process under consideration. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said the FDA needs a workable pathway not requiring new authority from Congress to deal with the growing sector. During…