Tagged: FDA

Senator Kay Hagan toured UNC Children's Hospital yesterday as part of a push for her bill that would streamline approval of treatments for serious and rare diseases.

Hagan says the Food and Drug Administration needs to find faster ways to get treatments to patients suffering from rare diseases.

The FDA has approved a Triangle company's method of treating dry-eye disease. The medical-device company TearScience announced today it will start producing its product called LipiFlow. TearScience president and CEO Tim Willis says it's a treatment that includes a series of procedures to open obstructed oil glands in the eyelids that usually keep eyes moisturized.

An FDA panel says removing menthol cigarettes from the market would benefit public health. The Food and Drug Administration advisory panel stopped short of recommending an outright ban on menthol cigarettes. But its report released earlier today says the minty flavoring in menthols makes it harder for smokers to quit.

The US Food and Drug Administration will require certain tobacco products introduced or changed after February of 2007 to be reviewed by the agency. Tobacco companies will have until March 22nd to apply for products to be approved as “substantially equivalent.” That means the products pose no added risk to smokers than products already available in early 2007.

David Howard is a spokesman for the Winston-Salem-based R.J. Reynolds Tobacco Company:

Tobacco workers employed by Lorillard plan to protest at an FDA meeting scheduled for tomorrow morning in Raleigh. The government is reviewing the safety of menthol cigarettes- Lorillard has a market share of about 35 percent of the product. The Bakery, Confectionery, Tobacco Workers and Grain Millers International Union Local 317-T in Greensboro is organizing the event. Randy Fulk is the union's international representative. He worked for Lorillard Tobacco for more than 36 years: