Glossary (Update In Progress)

Accelerated Approval: approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit

Fast Track, Fast Track Designation: a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

Priority Review: A designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months. Priority Review status can apply both to drugs that are used to treat serious diseases and to drugs for less serious illnesses. The FDA goal for reviewing a drug with Priority Review status is six months.