FDA Completes Recommendations for Three Drug User Fee Programs
The programs include the fifth authorization of the Prescription Drug User Fee Act, and new user fee programs for human generic drugs and biosimilar biological products.
The U.S. FDA has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients.
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.
Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA's drug review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame.
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