Prescription Drug User Fee Act (PDUFA)
The Issue
The Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and revised in 1997 and 2002, is a program under which the pharmaceutical/biotechnology industry pays certain "user fees" to the Food and Drug Administration (FDA). In return, the FDA has reduced the approval time for New Drug Application and Biological License Applications.
Our Position
We monitor the application of PDUFA at the FDA and support ongoing efforts to ensure quick but sufficient reviews of new drugs.
About MassBio
MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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