Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations. Rolling review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency's procedures for internal review or dispute resolution if necessary. 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. See also Orphan drug, a similar FDA designation References External links U.S. Dept. of HHS, FDA, CDER, and CBER, Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics, CENTER FOR DRUG EVALUATION AND RESEARCH, at 9 (June 2013), available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf. Fast track approvals FDA Food and Drug Administration Life sciences industry Pharmaceutical regulation in the United States