Archive for the ‘FDA Updates’ Category

Participants in a workshop sponsored by the National Institutes of Health have developed guidelines on designing and evaluating clinical research studies investigating soy, representing the first guidelines of their kind in the field of soy research. The guidelines are published in the June 2010 issue of The Journal of Nutrition.

Dr. Harold Varmus brings a vast wealth of expertise to this key leadership position at the Department. Among his many professional distinctions, he is a Nobel laureate in cancer genetics; has been president of one of the premier cancer research and treatment institutions for the past decade; and previously has served the public as NIH director in the 1990s.

HHS Secretary Kathleen Sebelius has appointed four new members to the National Advisory Council for Nursing Research (NACNR), the principal advisory board for the National Institute of Nursing Research (NINR). Members of the council are drawn from the scientific and lay communities, embodying a diverse perspective from the fields of nursing, public and health policy, law, and economics.

An important role of the council is to conduct a second level of review of grant applications that have been scored by scientific review groups. The council meets three times a year on the campus of the National Institutes of Health to provide recommendations on the direction and support of the nursing, biomedical, social, and behavioral research that forms the evidence base for nursing practice.

A genetic variant of a receptor in the brain’s reward circuitry plays an important role in determining whether the neurotransmitter dopamine is released in the brain following alcohol intake, according to a study led by researchers at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health. Dopamine is involved in transmitting the euphoria and other positive subjective effects produced by alcohol.

Two common operations for stress urinary incontinence (SUI) help women achieve similar levels of dryness, according to a team of urologists and urogynecologists who compared the treatments in a large U.S. trial supported by the National Institutes of Health. The study is being released online May 17, 2010, by the New England Journal of Medicine to coincide with a presentation at the annual meeting of the American College of Obstetrics and Gynecology. Results will appear in the June 3 print edition.

See the most popular pages and search terms on USA.gov last month.

Two findings from an NIH research network study provide new information on how much oxygen very preterm infants should receive starting on the first day of life and the most effective means to deliver it to them.

Scientists have identified a group of surface markers on cells linked to an aggressive type of breast cancer called estrogen receptor-negative cancer. In this preliminary study, estrogen-negative breast cancer developed when three markers, CD44+, CD49fhi, and CD133hi were present simultaneously on the surface of human cells taken from breast cancer patients and transplanted into a mouse;

this is called a xenograft model. The scientists named these human cells with tumor-forming ability in mice, xenograft-initiating cells, or XIC. The research, conducted by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health, appeared online May 18, 2010, and in print June 1, 2010, in Cancer Research.

During Healthy Vision Month this May, the National Eye Institute (NEI), part of the National Institutes of Health, is encouraging Americans to make vision health a priority and schedule an eye exam to help prevent unnecessary vision loss and blindness. Early detection and timely treatment can help save your sight and ensure that you’re seeing your best.

NCDEU is a scientific meeting that focuses on the latest developments in psychopharmacologic clinical trials research and related methodology. Co-sponsored by NIMH and the American Society of Clinical Psychopharmacology (ASCP), the meeting brings together over 1200 academic and industry investigators, research pharmacists, and clinicians and provides state-of-the-art workshops, panels, posters, and other special sessions devoted to advancing clinical research. Through its highly successful New Investigator Program, NCDEU emphasizes the development of research careers for those relatively new to the field of clinical research.

The NIMH Annual International Research Conference on the Role of Families in Preventing and Adapting to HIV/AIDS is a three-day conference addressing the importance of family in the fight against HIV/AIDS. Family is defined as a network of mutual commitment. Academic researchers and service providers come together to discuss the most effective approaches to working with families that are infected or affected by HIV/AIDS. This year, the conference will be held in Nashville, TN, and the theme will be HIV Prevention and Support for Families Living in Rural Areas. The first day, Community Day, is focused on working with community providers to respond to the social context of HIV risk and enhancing the role of families in preventing and treating HIV/AIDS. Over the course of the next two days, the latest scientific findings from HIV/AIDS family-based studies will be presented in symposia, workshops, and a poster session.

Latinos have higher rates of developing visual impairment, blindness, diabetic eye disease, and cataracts than non-Hispanic whites, researchers found. These are the first estimates of visual impairment and eye disease development in Latinos, the largest and fastest growing minority population in the United States. The research was part of the Los Angeles Latino Eye Study (LALES), which was supported by the National Eye Institute (NEI), part of the National Institutes of Health. LALES began in 2000 as the nation’s largest and most comprehensive study of vision in Latinos.

The National Institutes of Health announced today the awarding of 10 new Centers for Population Health and Health Disparities, designed to better understand and address inequities associated with the two leading causes of death in the United States — cancer and heart disease.

Researchers have shown that ranibizumab (Lucentis) eye injections, often in combination with laser treatment, result in better vision than laser treatment alone for diabetes-associated swelling of the retina.

Scientists have identified new genes and pathways that influence an individual’s typical pattern of brain electrical activity, a trait that may serve as a useful surrogate marker for more genetically complex traits and diseases. One of the genes, for example, was found to be associated with alcoholism.

The National Institute of Allergy and Infectious Diseases (NIAID), the lead institute at the National Institutes of Health for food allergy research, is pleased to commemorate Food Allergy Awareness Week from May 9–15, 2010. First established in 1997 by the Food Allergy and Anaphylaxis Network (FAAN), a patient and family advocacy organization, this week is set aside each year to focus public attention on this growing health problem. FAAN’s theme for this year, Respect Every Bite, reminds us of the daily threat faced by people with food allergy, as exposure to even trace amounts of allergenic foods can cause allergic symptoms.

The NIMH Office for Research on Disparities & Global Mental Health invites qualified and early career professionals to the Careers in Global Mental Health meeting on July 30, 2010. The meeting will bring together early career clinical and research professionals (including medical and public health students) for an interactive forum, with the goal of orienting them to research careers in global mental health. We encourage individuals (recent graduates in any of the following disciplines: medicine, psychiatry, neurosciences, psychology, social work, public health, epidemiology, anthropology, sociology and other relevant degrees) interested in developing their skills and knowledge for addressing global mental health challenges through innovative research to apply.

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