Posted on January 25, 2012 by Debra A. McCurdy

FDA Completes Work on Three Drug User Fee Programs

On January 13, 2012, the FDA announced that it has completed its recommendations for three user fee programs designed to help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients. The recommendations regarding the user fee programs were transmitted to Congress that same day by HHS Secretary Sebelius. The programs include the fifth authorization of the Prescription Drug User Fee Act (PDUFA), and new user fee programs for human generic drugs and biosimilar biological products.

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