The
User Fee programs help the Food and Drug Administration (FDA) to fulfill its
mission of protecting the public health and accelerating innovation in the
industry. The Office of Financial Management (OFM) is responsible for the
financial management of the user fee programs.
US FDA’s User Fee programs help FDA to hire
and retain sufficient numbers and types of technical and scientific experts
to efficiently conduct reviews of drug/device applications and
improving the predictability of review processes.
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FDA’s User Fee programs
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PDUFA - Prescription Drug User Fee
Act
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MDUFA - Medical Device User Fee Act
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GDUFA - Generic Drug User Fee Act
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BsUFA - Biosimilar User Fee Act
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ADUFA – Animal Drug User Fee Act
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AGDUFA – Animal Generic Drug User
Fee Act
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