August 20, 2014

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.

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.

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.

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.

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.

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.

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.

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.

February 28, 2013

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

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.

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.

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.

January 16, 2013

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

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.

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.”


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.

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.


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.

July 16, 2012

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

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.

July 10, 2012

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.

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. 


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.