Content about Prescription Drug User Fee Act

June 1, 2012

Five pharmacy organizations on Thursday wrote Congress in opposition of an amendment to the Food and Drug Administration Safety Innovation Act due to its potential to delay patients' timely relief from chronic pain while increasing drug costs.

ALEXANDRIA,Va. — Five pharmacy organizations on Thursday wrote Congress in opposition of an amendment to the Food and Drug Administration Safety Innovation Act due to its potential to delay patients' timely relief from chronic pain while increasing drug costs.
 

May 31, 2012

The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

WASHINGTON — The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

The bill, a version of which already passed through the Senate, now heads to committee where the House and Senate versions of the bill can be reconciled before Oct. 1 and submitted to the president. According to published reports, the Senate version would require more scrutiny for some new devices.

May 30, 2012

The House of Representatives will be debating H.R. 5651 Wednesday afternoon — a bill that, if passed, will reauthorize the Prescription Drug User Fee Act.

WASHINGTON — The House of Representatives will be debating H.R. 5651 Wednesday afternoon — a bill that, if passed, will reauthorize the Prescription Drug User Fee Act. 

The Senate passed a similar measure last week by a vote of 96-to-1 with three senators not voting.

May 21, 2012

Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.

NEW YORK — Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.

April 26, 2012

The National Association of Chain Drug Stores expressed its support for the legislative package that will serve as a starting point for the reauthorization of the Prescription Drug User Fee Act in a letter to the bipartisan leadership of the Senate Committee on Health, Education, Labor and Pensions.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores expressed its support for the legislative package that will serve as a starting point for the reauthorization of the Prescription Drug User Fee Act in a letter to the bipartisan leadership of the Senate Committee on Health, Education, Labor and Pensions.

April 25, 2012

The National Community Pharmacists Association has sent a letter to a Senate committee regarding legislation that would reauthorize the Prescription Drug User Fee Act.

ALEXANDRIA, Va. — The National Community Pharmacists Association has sent a letter to a Senate committee regarding legislation that would reauthorize the Prescription Drug User Fee Act.

January 31, 2012

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.

ALEXANDRIA, Va. — 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.

The National Association of Chain Drug Stores submitted written testimony Tuesday ahead of a congressional hearing on the reauthorization of PDUFA, originally enacted in 1992.

January 20, 2012

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.


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

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

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

August 23, 2011

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.

THOUSAND OAKS, Calif. — 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

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.

PHILADELPHIA — 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.

The FDA said it revised its PDUFA goal date of June 23 for Lannett's new drug application for morphine sulfate oral solution.

"With a revised PDUFA date in 17 days, we are preparing for the relaunch of our morphine sulfate oral solution product, if approved,” Lannett president and CEO Arthur Bedrosian said.

January 31, 2011

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.

POINT RICHMOND, Calif. — 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.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

January 17, 2011

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

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

The drug maker recently announced that the Food and Drug Administration asked AstraZeneca to submit a Risk Evaluation and Mitigation Strategy, which accordingly extended the Prescription Drug User Fee Act from Jan. 7 to April 7.

AstraZeneca will continue to work closely with the FDA to support the review of vandetanib, a drug for treating patients with advanced medullary thyroid cancer.

January 13, 2011

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.

ST. LOUIS — 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.

K-V, which acquired the injected drug Gestiva (hydroxyprogesterone caproate) from Hologic in 2008, said Hologic originally had been told the FDA would take action Thursday.

K-V said it was confident the drug would receive approval and that the FDA would take action on or before the new PDUFA date.

November 14, 2010

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

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.