July 22, 2015

The Generic Pharmaceutical Association has appointed Chester “Chip” Davis, Jr. as president and CEO, replacing current CEO Ralph Neas effective Aug. 18.

July 16, 2015

The Food and Drug Administration recently issued its final guidance on the appearance of generic pharmaceuticals, recommending that drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs that they reference.

July 16, 2015

Ralph Neas, president and CEO of the Generic Pharmaceutical Association, issued a statement last month criticizing the FDA at the organization’s public meeting on the Generic Drug User Free Act.

June 15, 2015

 "As it stands now, TPP will make it harder for the U.S. generic industry to sell its products overseas," GPhA's Ralp Neas reported. 

May 28, 2015

The AARP Public Policy Institute’s latest Rx Price Watch Report shows that, despite an overall 4% decrease in price in 2013, the prices of generic drugs seem to be dropping at the slowest rate since 2006. 

April 22, 2015

The dramatic increase in the price of generic drugs last year is expected to continue for the rest of 2015 and even into next year, according to those who closely monitor the market.

April 14, 2015

Taiwan-based drug development company Sunny Pharmtech and Vitruvias Therapeutics, a generic drug development company, on Tuesday announced that they will team up to co-develop a portfolio of generic drug products.

March 31, 2015

The director of the FDA’s Office of Generic Drugs temporarily steps down to deal with a medical issue, according to a report by the Regulatory Focus Professionals Society.

March 10, 2015

Impax Labs completed its acquisition of Tower Holdings (which includes operating subsidiaries CorePharma and Amedra Pharmaceuticals), and Lineage Therapeutics. Impax also announced that it would reshape both the operating and reporting structure of its two divisions.

February 5, 2015

Generic drug prices are going up. Spurred by market opportunities, short-term market exclusivity for some newly launched single-source generics and rising costs for manufacturing, quality control and raw materials, me-too drug manufacturers have escalated a series of price hikes, some of them significant.

January 20, 2015

Spurred by market opportunities, short-term market exclusivity for some newly launched single-source generics and rising costs for manufacturing, quality control and raw materials, me-too drug manufacturers have escalated a series of price hikes, some of them significant.

January 16, 2015

Kathleen "Cook" Uhl on Thursday was named director of the Food and Drug Administration's Office of Generic Drugs.

 

December 29, 2014

In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.

December 11, 2014

After a recent spike in the prices charged for some generic drugs led to outcries from pharmacists, patient advocates and federal lawmakers, a report issued last month suggests that drug costs can be controlled if the Food and Drug Administration changes the way it handles reviews and approvals.

 
November 20, 2014

The Generic Pharmaceutical Association on Thursday emphasized the savings generic medicines bring to the table in light of rising brand prices. 

October 15, 2014

As the Food and Drug Administration begins to explore ways to improve its user-fee program for generic drugs, the Generic Pharmaceutical Association and its members have weighed in with suggestions on how to shore up the law to ensure that it helps bring generics to market faster and provides benefits across the entire healthcare system.

September 24, 2014

In honor of the 30th anniversary of the Drug Price Competition and Patent Term Restoration Act — more commonly known as the Hatch Waxman Act — which enabled manufacturers to bring generic versions of pharmaceuticals to market more easily, GPHA president Ralph Neas issued a statement.

September 18, 2014

The Generic Pharmaceutical Association on Thursday provided input on the Generic Drug User Fee Act process before the Food and Drug Administration. 

September 10, 2014

The Generic Pharmaceutical Association on Wednesday released a report showing that generic drugs saved the United States health system $239 billion in 2013.

August 21, 2014

The generic drug industry — and by extension, patients across the United States — is being adversely impacted by what some are calling branded drug makers’ abuse of risk evaluation and mitigation strategies, or REMS.

August 18, 2014

The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. 

July 29, 2014

The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.

July 21, 2014

The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced.

June 18, 2014

Canada’s Federal Court ruled recently that the country’s Patented Medicine Prices Review Board — a federal tribunal that regulates pricing on branded medicines — could not extend price-control measures to cover generic drug companies, according to published reports.