FDA special designations: Impact on drug development

Abstract

CDER and CBER must always maintain a balance between thoroughness and speed regarding drug approval requirements and timelines. Requiring more study data than necessary and spending too much time completing the review of an NDA or BLA will delay access to a drug that could prove bene cial to patients. Alternatively, pushing a drug through the approval process too quickly increases the risk that the drug may not be as safe or effective as it originally appeared to be.