Content about Prescription Drug User Fee Act

December 26, 2013

The Food and Drug Administration has postponed the time it will decide whether or not to approve an experimental treatment under development by Takeda Pharmaceutical Co. for ulcerative colitis, the company said.

DEERFIELD, Ill. — The Food and Drug Administration has postponed the time it will decide whether or not to approve an experimental treatment under development by Takeda Pharmaceutical Co. for ulcerative colitis, the company said.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

When Congress approved a reauthorization of the Prescription Drug User Fee Act that included the Generic Drug User Fee Amendments last year, that backlog included about 2,500 applications. But thanks to GDUFA, the agency has managed to clear muchof it.

September 11, 2013

The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

SILVER SPRINGS, Md. — The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

In a memo to staff of the agency's Center for Drug Evaluation and Research, center director Janet Woodcock wrote that for fiscal year 2013, the FDA hired 234 people as part of the Generic Drug User Fee Amendments Human Capital Team. The goal was to hire 231 as part of a three-year push in which it hopes to hire 921, including 461 during fiscal year 2014.

September 10, 2013

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

July 9, 2013

The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said Tuesday.

June 18, 2013

The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

NEW YORK — The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

CDER director Janet Woodcock wrote that the FDA had collected more than $255 million under the Generic Drug User Fee Amendments to the 2012 Prescription Drug User Fee Act reauthorization. The agency plans to collect $299 million in fiscal year 2013.

April 30, 2013

The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

FOSTER CITY, Calif. — The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

February 28, 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

February 28, 2013

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

Leaders in both the branded and generic drug industries praised the reauthorization last June of PDUFA, the 20-year-old system by which research-based pharmaceutical companies help fund the government's expensive review and testing process for new drug applications.

February 28, 2013

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago.

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago. But IMS Health and other industry experts agree it could still be years before biosimilars are available to pharmacies and patients in this country.

February 22, 2013

One of the FDA's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered at the GPhA annual meeting.

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.

January 16, 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Wednesday.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

November 29, 2012

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


September 25, 2012

The generic drug user fee program may have hit a speed bump due to budget problems in Congress, according to published reports.

NEW YORK — The generic drug user fee program may have hit a speed bump due to budget problems in Congress, according to published reports.

Bloomberg reported that implementation of the law may be delayed because Congress must first pass legislation authorizing the Food and Drug Administration to collect money from generic drug companies, but the problem is that members of Congress will leave Washington this week, not to return until after the Nov. 6 elections.

September 18, 2012

2012 is turning out to be a pretty important year for generic drugs, important enough that some of the things happening over the past several months have begged comparison to 1984, probably the biggest milestone year for the industry.


2012 is turning out to be a pretty important year for generic drugs, important enough that some of the things happening over the past several months have begged comparison to 1984, probably the biggest milestone year for the industry.


August 23, 2012

The Food and Drug Administration has released draft guidance for the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has released draft guidance for the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the agency said.

A collection of documents posted on the FDA's website includes guidance for the generic drug industry on self-identification of generic drug facilities, sites and organizations, questions and answers about the draft guidance and others.

July 16, 2012

Is the reauthorization of the Prescription Drug User Fee Act “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act?”

Is the reauthorization of the Prescription Drug User Fee Act “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act?”

The generic drug industry’s chief spokesman and top lobbyist says so, at any rate. Ralph Neas, president and CEO of the Generic Pharmaceutical Association, called the newly enacted Food and Drug Administration Safety and Innovation Act “a remarkable achievement for patients, industry and the FDA.”

July 12, 2012

While most of the attention to the Prescription Drug User Fee Act reauthorization focused on what it would mean for the generic drug industry, one other aspect of the law recently drew applause from a group that advocates on behalf of the blind.

NEW YORK — While most of the attention to the Prescription Drug User Fee Act reauthorization focused on what it would mean for the generic drug industry, one other aspect of the law recently drew applause from a group that advocates on behalf of the blind.

July 10, 2012

President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

WASHINGTON — President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

June 22, 2012

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

MOUNTAIN VIEW, Calif. — A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Alexza Pharmaceuticals said it received a complete response letter for Adasuve last month from the regulatory agency. The CRL outlined the FDA's concerns about Alexza's manufacturing facility and the drug's draft product labeling. Alexza said it believes it has addressed these concerns in its resubmitted application.

June 21, 2012

Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


June 20, 2012

The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

The U.S. House and Senate passed their versions of PDUFA last month and worked to reconcile their individual bills into one final bill. Both chambers are expected to vote on the final conference report this week.

June 13, 2012

As the U.S. Senate and House reconcile their versions of the Prescription Drug User Fee Act, the National Association of Chain Drug Stores on Wednesday urged U.S. House and Senate leaders to expand provisions in the final bill to help ensure that Americans continue to have access to safe and effective prescription medications, while also curbing prescription drug abuse.

ALEXANDRIA, Va. — As the U.S. Senate and House reconcile their versions of the Prescription Drug User Fee Act, the National Association of Chain Drug Stores on Wednesday urged U.S. House and Senate leaders to expand provisions in the final bill to help ensure that Americans continue to have access to safe and effective prescription medications, while also curbing prescription drug abuse.

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.

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.