FDA’s Accelerated Pathways Are the New Normal

The FDA’s Accelerated Approval, Breakthrough Therapy Designation, Fast Track, Orphan Drug status, and Qualified Infectious Disease Product pathways facilitate faster development and approval of NDAs addressing unmet needs. According to the FDA’s annual report, two-thirds of novel drugs approved in 2015 used at least one accelerated pathway, while a third used two or more. PAREXEL and the nonprofit Network for Excellence in Healthcare Innovation share results of a survey of twenty national, regional, public, and private payers, which explain how they view these pathways and products.

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