Content about Regulatory and Washington

November 29, 2011

A drug designed to prevent stroke and systemic embolism in patients with atrial fibrillation has been accepted for review by the Food and Drug Administration.

November 29, 2011

The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.

November 29, 2011

Watson Pharmaceuticals subsidiary Watson Labs has received regulatory approval for a generic oral contraceptive.

November 28, 2011

The Obama administration confirmed last week that Centers for Medicare and Medicaid Services administrator Donald Berwick will step down from his post on Dec. 2.

November 28, 2011

Many elderly patients put themselves at risk for emergency hospitalization due to adverse drug events, according to a new Centers for Disease Control and Prevention study published in the New England Journal of Medicine.

November 28, 2011

The Food and Drug Administration has approved a generic drug made by Mylan for cancer patients.

November 28, 2011

The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.

November 28, 2011

The merger between pharmacy benefit managers Express Scripts and Medco Health Solutions "could bring an end to community-based pharmacies and the convenient services provided there," according to the Pennsylvania Pharmacy Council.

November 28, 2011

Perrigo on Monday announced that it received final approval from the Food and Drug Administration for its store-brand version of Mucinex tablets.

November 28, 2011

A coalition of retail organizations, including the National Retail Federation, the Food Marketing Institute and the National Association of Convenience Stores, have filed a lawsuit charging that the Federal Reserve failed to comply with a new law requiring it to reduce fees bank charge retailers when shoppers use credit cards.

November 28, 2011

A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

November 28, 2011

The National Committee for Quality Assurance on Monday named Jeffrey Kang, Walgreens SVP pharmacy, health and wellness services and solutions, to its board.

November 23, 2011

The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

November 23, 2011

The Food and Drug Administration has approved a professional glucose monitoring system made by Medtronic, the company said.

November 23, 2011

Pfizer is looking to sell its top-selling cholesterol drug directly to consumers at a greatly reduced price after the patent expires, according to published reports.

November 23, 2011

Facebook wars happen all the time, but it's not often that drug manufacturers duke it out online.

November 23, 2011

British drug maker Shire is looking to make a biotech drug for a rare genetic disorder at a new manufacturing plant in Massachusetts.

November 22, 2011

The recent approval of a 10% reimbursement rate cut in California’s Medicaid program, known as Medi-Cal, by the Centers for Medicare and Medicaid Services has prompted provider groups to file a lawsuit against the California Department of Healthcare Services and the U.S. Department of Health and Human Services, alleging that the cuts did not follow proper legal channels.

November 21, 2011

The Council for Responsible Nutrition on Monday announced that Rend Al-Mondhiry has joined CRN’s staff to serve as the trade association’s regulatory counsel.

November 21, 2011

After being unanimously recommended for approval by a Food and Drug Administration panel, the FDA has approved an eye disorder treatment created by Regeneron Pharmaceuticals.

November 21, 2011

Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

November 21, 2011

Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

November 21, 2011

Many so-called restricted-network Medicare Part D prescription drug plans don't give adequate pharmacy access to rural residents and are deceptively marketed to patients, the National Community Pharmacists Association said Monday.

November 18, 2011

The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.

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