The Food and Drug Administration announced three major regulatory initiatives designed to further implement the Dietary Supplement Health and Education Act of 1994 (DSHEA). These initiatives — a regulatory strategy, an open public meeting, and a draft guidance document for industry — are significant steps FDA has taken in the implementation of DSHEA.
The Food and Drug Administration approved the ExAblate 2000 System, a new medical device that uses magnetic resonance image guided focused ultrasound to target and destroy uterine fibroids, non-cancerous masses located in the uterus. The device is intended to treat women who have completed child bearing or do not intend to become pregnant.
The Food and Drug Administration has approved a Humanitarian Device Exemption (HDE) for an implanted device to treat children who have Thoracic Insufficiency Syndrome, a term used to describe patients who have severe deformities of the chest, spine, and ribs that prevent normal breathing and lung development.
Ranbaxy Laboratories Limited India has informed the World Health Organization (WHO) that it is voluntarily withdrawing all its antiretrovirals (all the product dossiers under assessment and all prequalified products) from WHO prequalification. This action was taken after the company found discrepancies in the documentation relating to proof of the products’ bioequivalence with originator medicines. The company has already presented WHO with a plan indicating proposed dates for the submission of new study reports for these products. The first study is expected to be completed by December 2004.
In 1999, almost 108 million adult Americans were overweight or obese. If you are overweight or obese, carrying this extra weight puts you at risk for developing many diseases, especially heart disease, stroke, diabetes, and cancer. Losing this weight helps to prevent and control these diseases. Following guidelines provide you with a new approach for the measurement of overweight and obesity and a set of steps for safe and effective weight loss.
The Food and Drug Administration (FDA) has approved a plastic lens that is permanently implanted into the eye to correct moderate to severe nearsightedness. The lens, called an intraocular lens (IOL), is similar to the type of lens implanted in the eye to restore vision following cataract surgery.
The Fourth World Health Organization (WHO) Global Forum on Chronic Disease Prevention and Control opened in Ottawa, Canada. The Forum brings together senior level country officials, international agencies and non-Governmental organizations, as well as chronic disease and public health experts from around the world to focus on the growing global burden of chronic diseases. Of the estimated 57 million global deaths last year, 33 million were attributed to chronic diseases such as cardiovascular diseases, cancers, diabetes and chronic respiratory diseases.
The Food and Drug Administration (FDA) has approved an artificial spinal disc for use in treating pain associated with degenerative disc disease (DDD). The device is intended to replace a diseased or damaged intervertebral disc.
With the launch of a new report, the Global Campaign Against Epilepsy (GCAE) is urging governments to improve treatment, services and prevention of epilepsy in the Western Pacific Region.
In this area, the focus has been on prevention of mother to child transmission (MTCT) of HIV infection. The World Health Organization (WHO) emphasizes that prevention of MTCT should be seen as one part of the comprehensive care of the HIV positive pregnant woman i.e., a holistic and life span approach.