FDA's Expedited Programs and Their Impact on the Availability of New Therapies.

The US Food and Drug Administration's (FDA's) Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy programs have been successful in facilitating the drug approval process and getting medications to patients quicker. To qualify for one or more of these FDA programs, a sponsor must meet specific criteria. Once a drug is given one or more designations, benefits can range from frequent meetings with FDA representatives to appointed FDA senior managers to facilitate the approval process.