PDUFA Meaning and
Definition
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PDUFA stands for the Prescription Drug User Fee Act. It is a legislation enacted by the United States Congress in 1992 to authorize the collection of fees from pharmaceutical companies seeking approval for new drugs or biological products from the Food and Drug Administration (FDA).
Under PDUFA, drug manufacturers are required to pay fees to the FDA when submitting a new drug application (NDA), supplemental application, or biologics license application (BLA). These fees are intended to provide additional resources to the FDA to support timely drug reviews and ensure public health and safety.
The primary objective of PDUFA is to expedite the drug approval process, reduce the time it takes for innovative drugs to reach the market, and enhance the predictability and transparency of the FDA's review process. This act established specific performance timelines for the FDA to review drug applications and provide a decision.
PDUFA has resulted in significant improvements in the drug approval process, enhancing the efficiency and effectiveness of FDA reviews. It has facilitated greater collaboration between the FDA and pharmaceutical companies, leading to more timely reviews and approvals of new drugs. The act has incentivized the development of innovative treatments and therapies, benefiting patients by providing them with faster access to potentially life-saving medications.
In summary, PDUFA is a legislative act that establishes a fee-based system to support the FDA's drug review process, with the aim of expediting approvals and bringing innovative drugs to the market more quickly.
Common Misspellings for PDUFA
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