Archive for the ‘FDA Updates’ Category
The U.S. Department of Commerce’s Office of Innovation and Entrepreneurship and Economic Development Administration (EDA), today announced a new $12 million innovation competition, in partnership with the National Institutes of Health (NIH) and National Science Foundation (NSF). EDA will award up to $1 million to each of six winning teams with the most innovative ideas to drive technology commercialization and entrepreneurship in their regions.
Working with mice, a team of researchers has pinpointed the location of bone generating stem cells in the spine, at the ends of shins, and in other
bones. The team also has identified factors that control the stem cells’ growth.
The research was conducted at the National Institutes of Health and other
institutions.
A consortium of scientists supported by the National Institutes of Health reported today that it has identified two human genes that, when inherited in a slightly altered form, may play a role in causing cleft lip and/or palate (roof of the mouth), one of the world’s most common congenital malformations.
Some depressed patients who don’t respond to or tolerate antidepressant medications may benefit from a non-invasive treatment that stimulates the brain with a pulsing electromagnet, a study suggests. This first industry-independent, multi-site, randomized, tightly controlled trial of repetitive transcranial magnetic stimulation (rTMS) found that it produced significant antidepressant effects in a subgroup of patients, with few side effects.
Including a coronary artery calcium score in a risk assessment for future heart disease events, such as heart attacks, provides a better estimate in some populations than a standard coronary risk factors assessment, according to research supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.
A series of imaging studies are revealing that the brain works differently in youth with bipolar disorder (BD) than in chronically irritable children who are often diagnosed with pediatric BD.
Many preventive measures for cognitive decline and for preventing Alzheimer’s disease—mental stimulation, exercise, and a variety of dietary supplements — have been studied over the years. However, an independent panel convened this week by the National Institutes of Health determined that the value of these strategies for delaying the onset and/or reducing the severity of decline or disease hasn’t been demonstrated in rigorous studies.
Prescription drug abuse means taking a prescription medication that is not prescribed for you, or taking it for reasons or in dosages other than as prescribed. Abuse of prescription drugs can produce serious health effects, including addiction. In 2008, according to the National Survey on Drug Use and Health, 15.2 million Americans age 12 and older had taken a prescription pain reliever, tranquilizer, stimulant, or sedative for nonmedical purposes at least once in the year prior to being surveyed.
A daily dose of a specific form of vitamin E significantly improved the liver disease, nonalcoholic steatohepatitis (NASH), according to a study funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health. Results were published April 28 online in the New England Journal of Medicine. In addition, Actos (pioglitazone), a drug used to treat diabetes, also improved many features of NASH but was associated with weight gain.
Commissioner of Social Security, today announced that the agency has released its Open Government plan. The plan, available at www.socialsecurity.gov/open, reflects the agency’s commitment to increase transparency, expand opportunities for citizen participation and collaboration, and make open government sustainable at Social Security. Three flagship initiatives are highlighted in the plan — the Spanish-Language Retirement Estimator, Online Service Enhancement, and an Online Life-Expectancy Calculator. These initiatives support the agency’s mission, goals, and objectives, as well as showcase the value of open government principles.
“I applaud President Obama’s commitment to opening the federal government to the people it serves and I am especially proud of the three flagship initiatives we have chosen to implement by the end of this year,” said Commissioner Astrue. “These initiatives signify Social Security’s ongoing commitment to transparency, citizen participation, and collaboration as we improve the services we provide to the public.”
Social Security’s Spanish-language Retirement Estimator will be the agency’s and the federal government’s first-ever non-English interactive Internet application — a tool that furthers transparency by offering the Spanish-speaking public an opportunity to get instant, personalized estimates of future retirement benefits. Last year, over three million people used the English-language version of this popular online service available at www.socialsecurity.gov/estimator.
As part of its Online Service Enhancement initiative, Social Security will unveil a new service-channeling tool that will help people more easily find the information and services they seek on the agency’s website www.socialsecurity.gov. A key feature will be the opportunity to go online to schedule an in-office appointment for those who are unable to use our online services to conduct all of their business. This idea was submitted by Christie Dickson, an employee of Social Security, and was one of the finalists for the President’s SAVE award. In developing this tool, the agency will collaborate with members of the public as well as with industry experts.
The agency also is developing an Online Life-Expectancy Calculator — a simple, but important tool to assist the public with retirement planning. Many people substantially underestimate life expectancy, and this new online service will add a measure of accuracy to retirement planning by providing average life expectancies at different ages based on the person’s gender and date of birth, and drawing on assumptions provided in the annual Social Security Trustees’ report.
“I look forward to continuing to translate the values of open government into lasting improvements in the way the agency makes decisions, solves problems, and addresses its challenges,” said Commissioner Astrue. “Social Security’s flagship initiatives will improve our services and further break down barriers between the American people and their government.”
Social Security encourages feedback on its Open Government plan. To view the plan and share your comments and ideas, please visit www.socialsecurity.gov/open.
During the eighth annual Healthy Vision Month observance this May, the National Eye Institute (NEI), part of the National Institutes of Health, encourages community organizations and the American people to make vision health a priority. This year’s theme, “Your Eyes are the Windows to Your Health,” highlights the importance of scheduling an eye exam to maintain good quality eye health and preserve the sense of sight.
In a 2005 national survey conducted by NEI and the Lions Clubs International Foundation, 70 percent of adults reported that the loss of eyesight would have a great impact on their daily lives — a 10 on a scale of 1 to 10. However, 26 percent reported they had not had an eye exam within the previous two years, and 9 percent reported never having had their eyes examined.
Unfortunately, an estimated 14 million Americans are visually impaired. In fact, the prevalence of myopia, or nearsightedness, was shown to have increased 66 percent in the past 30 years, according to a 2009 NEI study. About 11 million Americans have refractive errors — common vision problems such as nearsightedness, farsightedness, astigmatism, and presbyopia — that can be detected during an eye examination and simply remedied with glasses or contact lenses.
Americans can also become visually impaired or blind from eye diseases. Of adults age 40 or older in the United States, more than 2 million have glaucoma, more than 4 million have diabetic retinopathy, and more than 1.75 million have age-related macular degeneration. These numbers will continue to increase as the population ages. These and other eye diseases have few warning signs or symptoms but can be detected in their early stages through a comprehensive dilated eye examination. Early diagnosis is critical, as vision loss and blindness may be prevented through timely treatment.
During a comprehensive dilated eye exam, the pupils are dilated with eye drops so an eye care professional can examine the back of the eye to detect signs of eye conditions such as diabetic retinopathy, glaucoma, or retinal detachment. Refractive errors can also be detected during a comprehensive eye exam.
NEI is committed to educating the public about vision and eye health. NEI’s National Eye Health Education Program has developed a wide variety of resources and materials that can be used during Healthy Vision Month and throughout the year. Visit the NEI Healthy Eyes Toolkit at www.nei.nih.gov/healthyeyestoolkit to find free resources that can be used to educate the public about the importance of eye exams. The toolkit includes e-cards, text messages, fact sheets, drop-in news articles, web links, posters, stickers, bookmarks, public service announcements, and more.
For more information about Healthy Vision Month, visit http://healthyvision2010.nei.nih.gov/hvm.
The National Eye Institute, part of the National Institutes of Health, leads the federal government’s research on the visual system and eye diseases. NEI supports basic and clinical science programs that result in the development of sight-saving treatments. For more information, visit www.nei.nih.gov.
The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
References:
The Eye Diseases Prevalence Research Group. (2004). The Prevalence of Age-Related Macular Degeneration in the United States. Archives of Ophthalmology, 122(4):564-572.
The Eye Diseases Prevalence Research Group. (2004). The Prevalence of Diabetic Retinopathy Among Adults in the United States. Archives of Ophthalmology, 122(4):552-563.
The Eye Diseases Prevalence Research Group. (2004). The Prevalence of Open-Angle Glaucoma Among Adults in the United States. Archives of Ophthalmology, 122(4):532-538.
National Eye Institute, National Eye Health Education Program. 2007. 2005 Survey of Public Knowledge, Attitudes, and Practices Related to Eye Health and Disease. Rockville, MD: National Institutes of Health. Accessible at: http://www.nei.nih.gov/kap/2005KAPFinalRpt.pdf (PDF- 8.9 MB) .
Vitale, S., Cotch, M. F., & Sperduto, R. D. (2006). Prevalence of visual impairment in the United States. The Journal of the American Medical Association, 295(18), 2158–2163.
Vitale, S., Sperduto, R. D., Ferris III, F. L. (2009). Increased Prevalence of Myopia in the United States Between 1971–1972 and 1999–2004. Archives of Ophthalmology, 127(12): 1632–1639.
Two people with compromised immune systems who became ill with 2009 H1N1 influenza developed drug-resistant strains of virus after less than two weeks on therapy, report doctors from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Doctors who treat prolonged influenza infection should be aware that even a short course of antiviral treatment may lead to drug-resistant virus, say the authors, and clinicians should consider this possibility as they develop initial treatment strategies for their patients who have impaired immune function.
Some of the same brain mechanisms that fuel drug addiction in humans accompany the emergence of compulsive eating behaviors and the development of obesity in animals, according to research funded by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health.
An international research consortium has identified more than 800 genes that appear to play a role in the male zebra finch’s ability to learn elaborate songs from his father. The researchers also found evidence that song behavior engages complex gene regulatory networks within the brain of the songbird — networks that rely on parts of the genome once considered junk.
In a new study in mice, scientists have compensated for mutations in the Brca1 gene that can lead to cancer by deleting a second gene, which then lessens the probability of cancer. Mice Brca1-associated mammary tumors have significant similarities to human BRCA1- associated (BReast CAncer 1, early onset) breast cancer in regard to tumor aggressiveness, high incidence, mutations and genetic instability. The study, led by scientists at National Cancer Institute (NCI), part of the National Institutes of Health, and their colleagues, appeared online April 1, 2010 and in print April 16, 2010, in the journal Cell.
Higher rates of colorectal cancer incidence and mortality experienced by African-Americans may be driven largely by differences in health care utilization, and less by biology, according to a new study led by researchers from the National Cancer Institute (NCI), part of the National Institutes of Health.
The more obese a woman is when she becomes pregnant, the greater the likelihood that she will give birth to an infant with a congenital heart defect, according to a study conducted by researchers at the National Institutes of Health and the New York state Department of Health.