Food And Drug Administration-Meningococcal Disease-Bacterial Meningitis-Glaxosmithkline Plc

U.S. approves Glaxo meningitis vaccine for children

A GlaxoSmithKline logo is seen outside one of its buildings in west London, ahead of company results

WASHINGTON (Reuters) - U.S. regulators on Thursday approved a new children's vaccine from GlaxoSmithKline PLC that targets two common causes of bacterial meningitis, which can be fatal. The U.S. Food and Drug Administration said the vaccine, MenHibrix, is meant for children aged six weeks to 18 months and combines vaccines for meningococcal disease and Hib disease. The diseases are common causes of the infection. The FDA had rejected MenHibrix twice before, in 2010 and 2011, but GlaxoSmithKline said it had resolved regulators' questions about the vaccine's potency and efficacy. ... read more..

source:http://yhoo.it/MW5qWP

Food And Drug Administration-Gel Breast Implants-French Authorities-Warning Letter

Insight: In PIP implant scandal, a ragged safety net exposed

Plastic surgeon Denis Boucq poses with silicone gel breast implants manufactured by French company Poly Implant Prothese (PIP) in a clinic in Nice

LONDON (Reuters) - In June 2000, when American medical regulators posted a warning letter on the Internet about problems at a breast-implant maker in southern France, French authorities didn't pay much attention. A U.S. Food and Drug Administration (FDA) inspection had found some products manufactured by Poly Implant Prothese (PIP) were "adulterated," the letter said. French regulators say they can't be sure now if they even saw it on the FDA's website. ... read more..

source:http://yhoo.it/zksmZP