GPhA provides input on GDUFA to FDA
WASHINGTON — The Generic Pharmaceutical Association on Thursday provided input on the Generic Drug User Fee Act process before the Food and Drug Administration.
"GDUFA is a historic achievement for both FDA and the generic pharmaceutical industry," the association stated. "The association and its members fully support GDUFA objectives with 100% industry-generated funds. In fact, last year the industry contributed $300 million to support the three core public health aims of GDUFA: safety, access and transparency. For GDUFA to be successful it must be implemented in a way that is mindful of the realities of the generic drug marketplace, and continues to incentivize the development of generic drugs for patients."
GPhA urged the FDA to dedicate resources to address the growing backlog of abbreviated new drug applications and prior approval supplement submissions. GPhA also noted that a significant portion of the issues identified during the technical reviews can be classified as "easily correctable deficiencies." Industry can respond to these ECDs within a five day timeframe, GPhA stated.
"GPhA looks forward to the continued dialogue on improving GDUFA, particularly efforts to make generic drug approvals more predictable and consistent," the association added. "This could include more communication with applicants and continued meaningful interaction with the generic industry during agency development of new guidance or before agency enforcement of draft guidance as final."
Dollar General remains committed to Family Dollar deal
GOODLETTSVILLE, Tenn. — In response to the decision by the board of directors of Family Dollar Stores to reject Dollar General's tender offer to acquire all outstanding shares of Family Dollar for $80.00 per share in cash, Dollar General on Thursday stated that it remains committed to acquiring Family Dollar.
The company also stated that it remains confident in both its antitrust strategy and the analysis performed by its antitrust advisors.
"Dollar General has made every good faith effort to engage in constructive discussions with the Family Dollar board of directors," stated Rick Dreiling, chairman and CEO of Dollar General. "At each turn, despite Dollar General's superior proposals and to the detriment of the Family Dollar shareholders, the Family Dollar board has refused to engage, leaving Dollar General with no choice but to launch a tender offer," he said. "Rather than engaging with us in a meaningful and constructive manner, the Family Dollar board has continued its efforts to distract shareholders from the main issue at hand – that a superior proposal adequately addressing antitrust issues remains on the table. Through our tender offer, Dollar General has provided all Family Dollar shareholders a voice in this process, and we urge them to tender into our offer."
Family Dollar Stores donate $458,000 to Feeding America
CHARLOTTE, N.C. — Family Dollar Stores on Thursday announced a $458,000 donation to Feeding America. The amount includes donations from Family Dollar and customers at more than 8,200 Family Dollar stores during the retailer’s "Feeding Families, Fueling Hope" campaign. The donation translates to more than 4.5 million meals for children and families in need.
“At Family Dollar, helping families in crisis is very important to us,” stated Howard Levine, Family Dollar’s chairman and CEO. “We’re proud that our store teams and customers rallied behind such an important cause, and we know this donation will make a positive, lasting impact in communities we operate in, across the country.”
Second Harvest Food Bank of Metrolina in Charlotte hosted a check presentation for Family Dollar and Feeding America. Following the presentation, Family Dollar Team Members assembled 1,000 backpacks for the Charlotte food bank’s weekend backpack program.
“With 49 million people struggling with hunger, we know that we can’t solve the problem alone. We are happy that Family Dollar employees and customers are standing shoulder-to-shoulder with us to help ensure that kids and families in the communities we serve have enough food to eat,” said Leah Ray, SVP development at Feeding America.
Loading Post Please Wait...