Surprisingly, there is widespread support from both Democrats and Republicans that PDUFA needs to be reauthorized.
FORBES: PDUFA: One of Congress' most important health policy votes in 2012
Amgen responded in late January, and the FDA set a PDUFA data of July 25, 2010.
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This would result in the fifth version of PDUFA, which was first passed in 1992.
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The FDA is seeking to change that as Congress takes a fresh look at the PDUFA law this year.
But the PDUFA deadline came and went, without any official comment from Pfizer.
If anything, actions like PDUFA arguably made the agency too cozy with companies.
But so far, the PDUFA fees are used only to review the safety and efficacy of drugs before they are approved.
It is now up to Congress to keep PDUFA working and ensure the approval of one of the must-pass health policy legislations in 2012.
FORBES: PDUFA: One of Congress' most important health policy votes in 2012
After months of deliberations, the bill passed its first hurdle last week when the Senate Health Committee approved its version of a PDUFA bill.
FORBES: PDUFA: One of Congress' most important health policy votes in 2012
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).
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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
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.
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The PDUFA user fee program has been a great success over the past two decades, as the increased funding from the pharmaceutical companies has allowed the FDA to add about 200 staff members and reduce the drug review process by nearly half.
FORBES: PDUFA: One of Congress' most important health policy votes in 2012
And it does so to such a great degree that drug stocks tend to run up ahead of the so-called PDUFA date, a deadline by which the FDA must issue a public statement about whether a drug is approvable and what else a company needs to do to get it approved.
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.
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