June 11, 2012

With overwhelming support in both the U.S. House and Senate and the strong backing of President Obama, a reauthorization of the landmark Prescription Drug User Fee Act that funds new drug application reviews at the Food and Drug Administration is a near certainty, probably within days or weeks at most. But one amendment to the Senate's version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, could threaten both retail pharmacies and the patients they serve.

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.

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.

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.

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.

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.

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.

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.

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.


November 3, 2011

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.

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.

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.

January 17, 2011

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

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.

November 14, 2010

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