FDA Completes Work on Three Drug User Fee Programs


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The FDA recently completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biologic products to patients, according to FDA Commissioner Margaret A. Hamburg, MD. 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 biologic 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. The proposed user fee programs for generic drugs and biosimilars are modeled on the successful PDUFA program, “which has ensured a predictable, consistent, and streamlined premarket program for prescription drugs,” Dr. Hamburg said.

PDUFA was created by Congress in 1992 and must be reauthorized every 5 years. ■



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