CBER director Peter Marks outlines the top priorities at the Center this year that include updating the Center’s tissue guidance to reduce the risk of infectious disease transmission, applying the accelerated approval pathway to rare disease gene therapies, and providing general guidance on platform technologies.
Federal Register
Clinical Pharmacology Office Priorities Docket
Federal Register notice: FDA creates a public docket entitled “Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration’s Office of Clinical Pharmacology.”