U.S. Food and Drug Administration

FDA launches series of meetings on food-safety proposals

Thomson ReutersFebruary 28, 2013 18:30

By Toni Clarke WASHINGTON, Feb 28 (Reuters) - The U.S. Food and Drug Administration kicked off a series of public meetings on Thursday to explain its proposed new rules for improving the safety of the nation's food supply - and gain feedback on the potential regulations. The rules offer a framework for implementing the Food Safety Modernization Act, which was signed into law in January 2011. The law represents the most sweeping reform of food safety laws in more than 70 years.

FDA recalls J&J's orthopedic device because of fracture potential

Thomson ReutersFebruary 22, 2013 13:15

Feb 22 (Reuters) - The U.S. Food and Drug Administration on Friday said it has notified healthcare professionals of a Class I recall, the most serious type, of an orthopedic device made by Johnson & Johnson. The device, called LPS Diaphyseal Sleeve, is used in reconstructive knee surgery. It was recalled because of the potential for fractures, the FDA said. The agency said it has received 10 reports of incidents in which the device has malfunctioned. The affected devices were manufactured by Depuy, J&J's orthopedic unit, from 2008 to July 20, 2012.

UPDATE 1-Botox OK'd by U.S. FDA to treat overactive bladder

Thomson ReutersJanuary 18, 2013 19:15

* 33 million Americans suffer from overactive bladder * Analysts forecast more than $200 mln in additional sales * Allergan sees 2012 Botox sales of $1.76 bln to $1.8 bln Jan 18 (Reuters) - The popular Botox wrinkle treatment made by Allergan Inc has been approved to treat adults with overactive bladder who cannot tolerate or failed to be helped by other drugs for the condition, the U.S. Food and Drug Administration said on Friday.