Breakthrough Therapies: Become A Priority


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Product Description

    Many people with life-threatening diseases often have little options for treatment. Now the FDA is working with biopharmaceutical companies to address this gap with a new regulatory designation.
    The breakthrough therapy designation was provided for in the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law in July 2012. It aims to provide a new regulatory pathway with additional support and guidance from…

The FDA’s Expedited Programs