Prescription Drug User Fee Act (PDUFA)

February 27, 2012

In 1992, Congress passed the PDUFA, authorizing the FDA to collect fees from companies that produce certain human drug and biological products. Any time a company wants the FDA to approve a new drug or biologic prior to marketing, it must submit an application along with a fee to support the review process. In addition, companies pay annual fees for each manufacturing establishment and for each prescription drug product marketed. In exchange for industry fees, the FDA was to meet drug-review performance goals, which emphasize timeliness.

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