A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.
The Council for Responsible Nutrition announced that Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration, will be a keynote speaker at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry Sept. 18 to 21 in Park City, Utah.
A federal court in New York has dismissed a lawsuit alleging that Mylan infringed four of Teva Pharmaceutical Industries' patents when it sought Food and Drug Administration approval for a multiple sclerosis drug.
The creation of a clear approval pathway for biosimilar drugs remains a daunting task for the Food and Drug Administration, despite the fact that it's prescribed by law through the Patient Protection and Affordable Care Act. But when those lower-priced, generic versions of some staggeringly expensive bioengineered medicines do finally come to market, they're likely to have a profound effect on the nation's outlays for specialty pharmaceuticals.
The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.
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.
Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.
The healthcare industry continues to prepare for ACA implementation and the expected influx of newly eligible patients, said Emdeon's Kevin Mahoney. Many pharmacies are changing their staffing models in preparation for customers with expanded Medicaid benefits — especially as we approach the New Year. This is a good time for me to remind you to be thinking about your eligibility program.