How the US drug safety system should be changed
...e changes being subject to negotiation between the regulatory agency and industry. It also needs substantially more resources for the postmarketing study of drug safety. Strom concludes by proposing that an independent, nongovernmental organization is needed for nonregulatory tasks that are not within the missi...JCI table of contents: May 1, 2006
...is required for the function of insulin-reactive T regulatory cells AUTHOR CONTACT: Li Wen Yale University School of Medicine, New Haven, Connecticut, USA. Phone: (203) 785-7186; Fax: (203) 737-5558; E-mail: li.wen@yale.edu . View the PDF of this article at: https://www.the-jci.org/article.php?id=27030 ACC...T cell 'brakes' lost during human evolution
... cells, which are essentially "unprotected" by the regulatory Siglecs. This study may also explain the severe human reactions observed in a recent clinical trial using a T cell activating anti-CD28 antibody produced by TeGenero, Inc. All six healthy volunteers who received doses at 500 times lower than what ...UCI researchers to study health effects of exercise in children
...search studies, facilitate subject recruitment and regulatory compliance, and provide statistical expertise. In addition, a pediatric growth, stress and inflammatory mediator core laboratory will ensure optimal and efficient use of analytic resources. The laboratory will be directed by Frank Zaldivar, a pediatr...Dynamic duo: Combination therapy reverses type 1 diabetes
...st T cells. This antibody promotes the function of regulatory T cells (Tregs), which put the brakes on an overaggressive immune response. However, chronic "body-wide" suppression of the immune system in this way puts patients at risk for malignancies or reactivation of dormant viral infections, consequently dam...JCI table of contents, April 20, 2006
...st T cells. This antibody promotes the function of regulatory T cells (Tregs), which put the brakes on an overaggressive immune response. However, chronic "body-wide" suppression of the immune system in this way puts patients at risk for malignancies or reactivation of dormant viral infections, consequently dam...Conference calls for global approach to risk management in medicines, food, environment
...aders from industry and national and international regulatory bodies will share perspectives on the shifting landscape of risk management for pharmaceuticals, medical devices, healthcare networks, food production, environmental control, and transportation at "The Congress on Global Approaches to Risk Management...Better regulation needed for ethical research in Africa
...ethical conduct and argues that local and regional regulatory frameworks and legislation are needed to protect research participants in Africa. He suggests that regulations could provide guidance on forming local research ethics committees, informed consent procedures, standards of care, and distributive justic...What is pharmacology's place in finding alternatives to alcohol?
..., by Robin Room, Stockholm University, Sweden The regulatory challenges in engineering a safer tipple, by Wayne Hall, University of Queensland, Australia As Prof Nutt, Editor-in-Chief of Journal of Psychopharmacology, outlines in his piece, "Alcohol is a growing problem worldwide that some believe may have ...UC Berkeley team helps win approval for life-saving drug for African women
... for Venture Strategies, constructed the technical regulatory application for misoprostol's approval in Nigeria. Venture Strategies is also playing a central role in these efforts. "Some of our work is best conducted through a private organization," Campbell said. "I founded Venture Strategies in 2000 to draw...Cystic fibrosis research could benefit from multi-functional sensing tool
...ut little is known about how oxygen stress affects regulatory networks and alters chemoreceptors. To gain insights, the Georgia Tech researchers will study ATP, which is among the signaling molecules released by the carotid body. Researchers incorporate the same technology used for the multi-functional scannin...Experts call for balance in addressing under treated pain and drug abuse
...rescinded the DEA's new authority. As healthcare's regulatory authority shifts from health agencies to law enforcement agencies, the DEA and Federal prosecutors have used the courts to bypass state medical boards when scrutinizing physician practices. Dr. Fishman says that the recently passed national law, Nati...Racial disparities in access to medicines increase after implementation of prescription surveillance
...kely to be a problem in other states that use this regulatory approach. While decreasing abuse of the medications is desirable, these findings indicate that decreasing appropriate prescribing and access to benzodiazepines can have a negative affect on already vulnerable populations. "The specific ways in which ...National Academies news: Polio antivirals should be developed
...lopment and outlines steps for clinical trials and regulatory approval. The World Health Organization currently plans to stop using oral polio vaccine three years after the detection of the last case of transmission of wild polio virus. This is because the vaccine contains live, weakened polio viruses that can...Marrow-derived stem cells deliver new cytokine to kill brain tumor cells, offer protection
... Research, and the researchers are now applying to regulatory agencies to translate their work into human clinical trials. Gliomas are highly invasive tumors with poorly defined borders that intermingle with healthy brain tissue, making complete surgical removal nearly impossible. Furthermore, cells separate fr...Isolated female rats subjected to a 30-minute stressor heal faster than males
...xts, may function as part of an alternative stress regulatory system that facilitates wound healing," the authors wrote. Another possibility is that male and females experience stress differently, the study said. If females perceive the restraint as more traumatic, they may react more strongly to the stress ass...Ginkgo biloba extract: More than just for memory?
...ia uses cholesterol to produce steroids, which are regulatory hormones that, among other functions, help a cell grow, Papadopoulos said. "In fact, we have found that most life forms, including plants, insects, and animals, have receptors like these that help regulate growth." So they looked at whether cancer ce...Organic diets lower children's exposure to two common pesticides
...eas has either been banned or restricted by recent regulatory changes," Dr. Lu continues. "This helps to minimize children's exposure, but still few restrictions have been imposed in agriculture." In his initial research, Dr. Lu and his colleagues from Emory University, the University of Washington, and the Cen...Research links coverage by top current affairs programme to rise in adverse drug reports
...K in October 2002, May 2003 and October 2004. Five regulatory announcements made in the UK during the same perio...100,000 prescriptions. The change before and after regulatory announcements went from 7.6 to 8.0." SSRI's are used to treat patients with depression. They work b...... Mark Trial an important milestone on the path to regulatory approval. The VentrAssist: has been implanted, ...nical trials which are a prerequisite to obtaining regulatory approvals. We consider that we are well-positioned to take a significant role in the global market f...