Content about Prescription Drug User Fee Act

January 31, 2012
PDUFA reauthorization goals draw support from NACDS

A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country's main chain retail pharmacy lobby.

January 20, 2012
GDUFA reduces wait time for generics

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


November 3, 2011
FDA report: 35 new drugs approved in past year

The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

August 23, 2011
Amgen expects FDA decision on new indication for cancer drug by next April

The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

June 7, 2011
Lannett gets PDUFA date for morphine sulfate oral solution

Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

January 31, 2011
Transcept announces PDUFA action date for Intermezzo

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

January 17, 2011
FDA extends review time of AstraZeneca's vandetanib

A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

January 13, 2011
K-V: FDA will approve Gestiva by PDUFA date

K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

November 14, 2010
FDA generic user fees moving closer to reality

A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the...

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