Food and Drug Administration Amendments Act of 2007 - Prescription Drug User Fee Act

Prescription Drug User Fee Act

The Prescription Drug User Fee Act (PDUFA) (IV) was first enacted in 1992 to allow the FDA to collect “user fees” from biotechnology and pharmaceutical companies. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007. The purpose of these fees is to provide resources to the FDA that help them more effectively review potential new drugs. The most recent reauthorization will further expand on the previous policy. It aims to broaden and upgrade the drug safety program, allocate more resources for television advertising, and theoretically allow the FDA to more efficiently review and approve safe and effective new drugs for consumers.

Read more about this topic:  Food And Drug Administration Amendments Act Of 2007

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