FDAAA—An Abbreviation in Search of Understanding

Posted 01 February 2008 | By

Every five years since the original Prescription Drug User Fee Act of 1992 (PDUFA), Congress has orchestrated a litany of intricate legislative maneuvers by which-in exchange for continued authorization of user fees-industry and FDA alike have been inundated with new rights, duties, liabilities and deadlines. In 1997, this process resulted in the Food and Drug Administration Modernization Act (FDAMA).1 Five years later, 2002 brought us another PDUFA2 and the advent of device user fees via the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).3 And 2007 brought yet another legislative dance, but this time in a far different regulatory, legislative and political climate.

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