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Trends that Matter for FDA Regulation

Posted by Matt Breese on Oct 6, 2016

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A collection of engaging infographics from healthcare influencers to highlight general trends in FDA approvals and regulation in pharma:

Understanding the designation of pharmaceuticals during the FDA approval process is critical in pharma. Genentech breaks down the various designations, from "breakthrough therapy" to "fast track" and "priority review".



The FDA's breakthrough program is a popular topic when it comes to pharma regulation. The most common therapeutic areas when it comes to breakthrough designations include: oncology, infectious disease, metabolic, neurology and autoimmune, according to Citline.



As we all remember, 2015 was a record setting year when it comes to FDA approvals. Nearly 50% of those approvals were for drugs treating rare diseases with an average investment of $2 billion each. Via ALSA.



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