Specialty Drug Approvals: 2015 Highlights + 2016 Projections
In 2015, the recent trend continued with a greater-than-average number of drug approvals compared to past years. Special FDA designations such as breakthrough, fast track, orphan, accelerated approval and priority review have been applied to promising drugs or those that treat diseases with an unmet medical need. These designations have reduced the time needed for clinical trials and/or reduced the FDA review timeline, allowing pipeline products to come to market more quickly than in the past.1
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1. Developing products for rare disease & conditions. U.S. Food and Drug Administration (FDA) Website. Accessed December 1, 2015.
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