Keyword Analysis & Research: pdufa

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What does PDUFA stand for?

PDUFA stands for the Prescription Drug User Fee Act, which is a law allowing the Food and Drug Administration to charge companies that file new drug applications. The money goes toward expediting the review process that takes six months for drugs with an accelerated approval and 10 months for a standard filing.

What does PDUFA mean?

Legislative history. The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.

What is a PDUFA date?

A PDUFA date serves as a goal date for the FDA to make a decision about whether or not to approve new medications. The FDA is normally given 10 months to review a new drug after the filing application is accepted.

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