Drug | Page 269 of 280 | SpiritIndia.com

Breast cancer :: Test for breast cancer recurrence and chemotherapy

A new test can predict both the risk of breast cancer recurrence and may identify women who will benefit most from chemotherapy, according to research supported by the National Cancer Institute (NCI), part of the National Institutes of Health, and performed in collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health Inc. These results suggest that almost half of 43,000 U.S. women diagnosed with estrogen-dependent, lymph-node negative breast cancer every year are at low risk for recurrence and may not need to go through the discomfort and side effects of chemotherapy.

Cholesterol :: Understanding cholesterol and tips to manage high cholesterol

Cholesterol is essential for human life. It builds and repairs cells, it is used to produce sex hormones like estrogen and testosterone, it is converted to bile acids to help you digest food and it is found in large amounts in brain and nerve tissue. The liver produces enough cholesterol to satisfy these functions. Concerns associated with cholesterol starts when intake from foods like meat, particularly organ meats like liver and kidney, eggs, dairy and other “animal” food sources exceed recommended levels.

Health risks associated with unpasteurized juice

The Food and Drug Administration today reminded consumers of the dangers associated with drinking unpasteurized fruit and vegetable juices. This warning follows reports that the New York State Departments’ of Health and Agriculture and Markets, and local health departments in northern New York are investigating a recent foodborne disease outbreak possibly linked to the consumption of unpasteurized apple cider.

Guidance for Industry for new plant varieties intended for food use

To address the possibility that material from a new plant variety intended for food use might inadvertently enter the food supply before its sponsor has fully consulted with the Food and Drug Administration (FDA), FDA is announcing the availability of a draft guidance document entitled “Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.”

Guidance for Generic Drugs

The Food and Drug Administration (FDA) announced that a Guidance for Industry entitled “Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Questions and Answers”.

Multiple Sclerosis :: Natalizumab – antibody treatment for Multiple Sclerosis

FDA today licensed a new biologic approach to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of symptom flare-ups or exacerbations of the disease. MS is a chronic, often disabling disease of the brain and spinal cord.

Ultrasound :: Ultrasound-aided therapy better than stroke drug alone

Using ultrasound in combination with the drug t-PA can improve response to an ischemic stroke, according to a study involving 126 patients. This first-of-its-kind human trial compared the safety and efficacy of ultrasound and t-PA versus use of t-PA alone. The trial was funded in part by the National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health (NIH). The finding appears in the November 18, 2004, issue of the New England Journal of Medicine.

Nutrition :: Major Initiatives for Dietary Supplements

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.

Uterine Fibroids :: New Device to Treat Uterine Fibroids

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.

Respiratory :: Device to Treat Thoracic Insufficiency Syndrome

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.