FDA Finalizes Guidance on Expedited Drug Review Programs

The Food and Drug Administration issued a new guidance for industry on agency policies and procedures related to expedited drug development and review programs. The guidance, titled ‘‘Expedited Programs for Serious Conditions—Drugs and Biologics” (here), provides a “single resource” for information on FDA emergency expedited review, including fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation, said FDA. It addresses the applicability of expedited programs to rare diseases, clarification on available therapy, and flexibility in manufacturing and product quality, among other things.