Federal regulators want to hear from companies using engineered micro-particles in their products, part of an effort to stay abreast of the growing field of nanotechnology. The U.S. Food and Drug Administration issued final recommendations Tuesday for companies using nanotechnology in products regulated by the government, which can include medical therapies, food and cosmetics.
The government's top drug abuse experts are struggling to find ways to expand use of a medicine widely considered the best therapy for treating heroin and painkiller addiction, but which remains underused. Senator Carl Levin of Michigan on Wednesday pressed government officials and agencies to increase access to the buprenorphine, a drug which helps addicts control drug cravings and withdrawal symptoms.
Much as human DNA can be used as evidence in criminal trials, genetic information about microorganisms can be analyzed to identify pathogens or other biological agents in the event of a suspicious disease outbreak. The tools and methods used to investigate such outbreaks belong to the new field of microbial forensics, but the field faces substantial scientific and technical challenges, says a new report from the National Research Council.
Patients who use medical marijuana for pain and other chronic symptoms can take an unwanted hit: Insurers don't cover the treatment, which costs as much as $1,000 a month. Once the drug of choice for hippies and rebellious teens, marijuana in recent years has gained more mainstream acceptance for its ability to boost appetite, dull pain and reduce seizures in everyone from epilepsy to cancer patients.
Federal health regulators have cleared a genetic test from Roche as the first ever U.S.-approved alternative to the Pap smear, the decades-old mainstay of cervical cancer screening. The U.S. Food and Drug Administration approved Swiss-based Roche's cobas HPV test to detect the human Papillomavirus, or HPV, in women 25 and up. HPV causes nearly all cases of cervical cancer.
A 10-year-old girl who died of brain cancer is leaving a legacy for other sick children in a new law signed by President Barack Obama. The legislation calls for eliminating taxpayer funding for political conventions and redirecting it to pediatric research at the National Institutes of Health.
Novartis said it's cutting off late-stage research into a potential chronic heart failure treatment because the drug has proven so effective, sending shares to an all-time high when markets opened Monday. Patients taking its twice-daily pill labeled LCZ696 lived longer without being hospitalized for heart failure than those who received a standard of care, Novartis said.
Scientists who accepted the Bill & Melinda Gates Foundation's challenge to reinvent the toilet showcased their inventions in New Delhi on Saturday. The primary goal: to sanitize waste, use minimal water or electricity and produce a usable product at low cost. The World Bank estimates the annual global cost of poor sanitation at $260 billion and India is by far the worst culprit.
The federal government has signed off on a long-delayed study looking at marijuana as a treatment for veterans with post-traumatic stress disorder, a development that drug researchers are hailing as a major shift in U.S. policy. The Dept. of Health and Human Services' decision surprised marijuana advocates who have struggled for decades to secure federal approval for research into the drug's medical uses.
Over the past 20 years, the number of laboratory tests available to primary care physicians has doubled, to more than 3,500 tests, and physicians are challenged by the quantity of tests available. A recent survey conducted by the U.S. Centers for Disease Control and Prevention suggests they often face uncertainty in ordering and interpreting clinical laboratory tests, and would welcome better electronic clinical decision support tools.
Databanks containing information and biological materials from individuals are a crucial resource for research, but they are currently accessible only to researchers. In a recent paper published in Science, experts say that donors should have unrestricted access to data derived from their own material and that advanced technology means allowing such access is today a question of will rather than feasibility.
After 20 years, the nutrition facts label on the back of food packages is getting a makeover. Knowledge about nutrition has evolved since the early 1990s, and the U.S. Food and Drug Administration (FDA) says the labels need to reflect that. Nutritionists and other health experts have their own wish list for label changes.
Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood by the U.S. Food and Drug Administration (FDA). But a new study by researchers at Yale School of Medicine shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness.
A panel of federal experts has recommended approval for an experimental blood thinner from Merck despite serious side effects including internal bleeding. The Food and Drug Administration's panel of cardiology experts voted 10-1 Wednesday in favor of approving the pill vorapaxar to help prevent blood clots in patients with a history of heart attacks.
Although complications from surgical care for cancer patients may seem infrequent, the costs associated with such outcomes are extremely high, according to researchers from Rice Univ.’s Baker Institute for Public Policy and the Univ. of Texas MD Anderson Cancer Center.
A new study has found that people enrolled recently in Medicaid went to the emergency room 40 percent more frequently than others, often seeking help for conditions that could be treated less expensively in a doctor's office or an urgent care clinic.
The government is preparing to regulate the new field of hand and face transplants like it does standard organ transplants, giving more Americans who are disabled or disfigured by injury, illness or combat a chance at this radical kind of reconstruction. The United Network for Organ Sharing, or UNOS, will develop the new policies over the next few months.
A new study by researchers at the Univ. of California, Los Angeles and McGill Univ. reveals that the U.S. health care system ranks 22nd out of 27 high-income nations when analyzed for its efficiency of turning dollars spent into extending lives. The study illuminates stark differences in countries' efficiency of spending on health care, and the U.S.'s inferior ranking reflects a high price paid and a low return on investment.
Counselors helping people use the federal government's online health exchange are giving mixed reviews to the updated site, with some zipping through the application process while others are facing the same old sputters and even crashes. The Obama administration had promised a vastly improved shopping experience on healthcare.gov by the end of November, and this is the first week for users to test the updated site.
Biogen Idec said Monday the U.S. Food and Drug Administration (FDA) extended its review of Alprolix, a drug designed to treat hemophilia B. Biogen Idec said the FDA extended its review by three months. The move came after the agency asked Biogen for more information about validation of part of the Alprolix manufacturing process.
The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits. In a warning letter posted online Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of email exchanges."
Government cancer experts say a drug from Roche has shown effectiveness as a new option to treat breast cancer before tumor-removing surgery. The U.S. Food and Drug Administration panel voted 13-0, with one abstention, that the benefits of Perjeta as an initial treatment for breast cancer outweigh its risks.
Federal regulators have approved Celgene Inc.'s drug Abraxane to treat late-stage pancreatic cancer. In experimental trials, the drug extended the lives of patients by a little less than two months more than those treated with the current standard drug.
Despite widespread adoption by hospitals of surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins researchers. When an adverse event or device malfunction occurs, hospitals are required to report these incidents. But this doesn’t always happen, the researchers say.
Scientists estimate that there is a minimum of 320,000 viruses in mammals awaiting discovery. Collecting evidence of these viruses, or even a majority of them, they say, could provide information critical to early detection and mitigation of disease outbreaks in humans. This undertaking would cost approximately $6.3 billion, or $1.4 billion if limited to 85% of total viral diversity.