BioCentury's websites will be down for upgrades starting at 9 p.m. PDT on Monday, August 26. We expect the downtime to last no more than 6 hours, and we apologize for any inconvenience.

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...

Read the full 394 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >