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12:00 AM
Jan 23, 2006
 |  BioCentury  |  Regulation

The industry team

This Time, a Fishbowl

The industry team

Unlike taxes, the amount of user fees levied, as well as the ways the funds are spent, are subject to negotiations between industry - represented by trade associations - and FDA. These negotiations are then subject to review and modification by Congress, which must approve the final five-year Prescription Drug User Fee Act package.

The biotechnology industry was not at the table when PDUFA was created in 1992, but the industry has played an active role...

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