Tag: "regulatory" at medical news

Initially recommended drug dosages often too high, study finds

...980 and 1999. The team was led by James Cross, MS, regulatory project manager in the FDA's Center for Drug Evalu...tive subsequent to the drug's approval, changes in regulatory practice, and misjudgements made in the early phases of new drug development. All the researchers ag...

Pivotal brain processor decreased in schizophrenia

... 2000 for his work on DARPP-32. "DARPP-32 is a key regulatory protein, involved in controlling receptors, ion ch...rst study to show reduced levels of this important regulatory molecule in schizophrenia," said Bunney. "If DARPP-32 plays such a key role in controlling physiolog...

Making individual health insurance market work

... and protect high risks don't need to look to such regulatory schemes as community rating because most already have in force a strong policy tool, according to a new article published today on the Health Affairs Web site. Nearly every state requires insurers selling individual policies to guarantee that enrolle...

New overview adds more evidence for safety of third generation Pill

...ctors for MI are safe when used according to their regulatory labels. The absolute rates of occurrence of MI among users in reports since 1995 are low - unequivocally lower than those reported earlier between 1966 and 1995." The researchers concluded that a worst interpretation of their overview still favours ...

Former insider hits out at FDAs links with pharmaceutical industry

... and the FDA deny any inappropriate influence over regulatory decision making....

Study finds outbreak of Cipro web sites followed anthrax outbreak

... to the states but the states have not filled the regulatory vacuum." Tsai said he was inspired to undertake the research project after studying the work of other researcher-activists. Sehgal teaches an "Activism and Medicine" elective class for CWRU medical students. More information about this class can be ...

Group offers guidelines on qualifications

...d educators, as well as representatives from state regulatory agencies, companies that manufacture hybrid equipm...g the distribution of the consensus paper to state regulatory agencies, the next step is for a task force appointed by the ASRT and SNMTS to determine appropriate...

Atorvastatin shown to decrease heart disease and stroke (more follows)

...ormed fellow investigators, their patients and the regulatory authorities about the newly emerged results. The rest of the trial, which compares different blood pressure treatment strategies, will continue unchanged. "The trial shows that patients with high blood pressure but low cholesterol benefit clearly fro...

EXANTA (TM), an oral direct thrombin inhibitor, significantly reduces risk of VTE in major OS

... EXANTA is the first Oral DTI to be submitted for regulatory approval and works by inhibiting thrombin, a key e...opaedic surgery in July 2002. This was the first regulatory submission for EXANTA. In the United States, the orthopaedic surgery trial programme, EXULT, remain...

University of Pittsburgh researchers link gene to depressive disorders in women

... gene for mood disorders. The CREB1 gene encodes a regulatory protein (CREB) that orchestrates the expression of large numbers of other genes that play important roles in the brain. Alterations in CREB1 expression have been reported in the brains of patients who died with major depression, those of animal mode...

The pharmaceutical industry as political player

...uses on the political dynamic between industry and regulatory authorities. John Abraham from the University o..., or unnecessary. He concludes: "The present drug regulatory systems are insufficiently robust in their political relations with the pharmaceutical industry, bec...

Has drug regulation abandoned its public health mission?

...anaged to achieve an unhealthy influence over drug regulatory agencies, which may be threatening the public heal...s BMJ. Professor John Abraham argues that European regulatory authorities, which were initially established to provide independent scrutiny of pharmaceutical firm...

48-week results for the SOLO trial comparing GW433908/r QD to nelfinavir BID

...OLO, the second of three pivotal trials to support regulatory submission of 908, adds to the results of the NEAT trial presented earlier this year at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The primary endpoint of the NEAT trial is the proportion of subjects with vRNA...

World's largest scientific society announces subjects, dates for 2003 ACS ProSpectives Conferences

... building organic molecules while operating within regulatory constraints. Kumar Gadamasetti, X-Mine, Inc; Mike Martinelli, Eli Lilly Condado Plaza Hotel San Juan, Puerto Rico Feb. 2-5, 2003 Polymorphism in Crystals: Fundamentals, Prediction, and Industrial Practice The state-of-the-art in the often-misunder...

Integration of agriculture, medicine requires new ways of thinking

...and disease but cautions that product development, regulatory processes and consumer acceptance are realities that stretch the marketplace timeline far into the future. Other speakers in the symposium are: Charles J. Arntzen, Arizona State University: "When Agriculture and Medicine Merge." Jeffrey Burkhardt...

Competition among Medicare health plans not a cure-all

...edicare+Choice's performance under the payment and regulatory constraints of the Balanced Budget Act of 1997, as well as the lessons it has for the current debate on whether and how to expand Medicare benefits and modernize the Medicare program. Medicare managed care plans expanded rapidly during the 1990s, wh...

Economic evaluation shows add-on therapy with Keppra(r) is a cost-effective alternative

...ease consult your national Product Information and regulatory status as they may differ from one country to the other....

Nationwide improvement in nursing home care not likely, despite some changes

...Wiener of the Urban Institute. Despite substantial regulatory oversight, noted Dr. Wiener, "quality of care in nursing homes remains problematic." He added: "Quality of care in nursing facilities remains a major problem for which there are no simple solutions." Dr. Wiener made this assessment of care in nursing...

Experts meet to challenge approaches of testing and developing cancer treatments

...ional leaders in oncology and drug development and regulatory scientists will debate and identify improvements to intensify and accelerate clinical evaluation of novel oncology therapies. Although cancer shares characteristics of other life-threatening chronic diseases, it is often called a different disease ...

Smart virus eliminates brain cancer in animal experiments

...brake on cell division by preventing certain other regulatory proteins from triggering DNA replication. If the Rb protein is missing or non-functioning, a cell can replicate itself over and over, resulting in the development of a tumor. In normal cells, the Rb protein also prevents a virus that enters a cell f...

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