That was when the FDA had a deadline, under the Prescription Drug User Fee Act, to let Pfizer know its decision on the drug.

FORBES: Pfizer Plays A Guessing Game

Dyax submitted its reply on June 1, 2009, and the FDA set a decision deadline of December 1 under the Prescription Drug User Fee Act (PDUFA).

FORBES: How Long Will It Take For Arena's Obesity Drug To Be Approved?

Instead, the Senate is going to vote soon on a bill that reauthorizes the Prescription Drug User Fee Act (PDUFA), which is set to expire later this year.

FORBES: PDUFA: One of Congress' most important health policy votes in 2012

Since the advent of the Prescription Drug User Fee Act in 1992, biotech investors have come to expect the agency to be far more predictable than it actually is.

FORBES: Blindsided

Drug safety legislation could be coupled to the re-approval of the Prescription Drug User Fee Act, a 1997 law that sped up drug approvals by getting drug firms to help pay for the process.

FORBES: Magazine Article

Last time FDA had its budget clipped (by a much smaller amount) it used the shortfall as reason to back off some of its commitments under the Prescription Drug User Fee Act (PDUFA) to review applications on pre-determined timetables.

FORBES: Will Sequester End Drug Approvals? Not Unless White House Wants it to

For several years, drugmakers have been paying fees when they file new drug applications that the FDA uses to pay its reviewers, under a law called the prescription drug user fee act, or PDUFA. In return, the FDA promises to deliver some decision--even if it's just "needs more data"--by a given date, called the PDUFA date.

FORBES: Medicine's Two-Headed Watchdog