“Breakthrough” Designation … Another Powerful Tool in FDA's Toolbox for …

“Breakthrough” Designation … Another Powerful Tool in FDA's Toolbox for …

In fiscal year 2012, FDA approved 35 novel new drugs, also known as “new molecular entities.” Among these new products were drugs to treat patients with unmet medical needs, such as a groundbreaking treatment for a form of cystic fibrosis, the first 

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