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The FDA announced in early November that it was strengthening its safety program for marketed drugs. Lester M. Crawford, DVM, PhD, acting FDA commissioner, says that he has authorized the Center for Drug Evaluation and Research (CDER) to take the following measures.
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IRB processes are so varied from hospital to hospital that they can unnecessarily impede multicenter trials, according to a survey that looked at the responses of 68 hospitals to one study.
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Disappointed by a funding gap in the federal support of stem cell research, the citizens of California have made the decision to directly involve the State in the research effort.
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The St. Louis-based genomic medicine development company GenoMed is taking a novel approach to testing its hypothesis that inflammation-reducing heart medications can be effective in treating severe complications of influenza.
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Public opinion of FDA sliding in Vioxx wake; CAM therapies must meet standards.
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Should a terminally ill 10-year-old have a say in determining her end-of-life care? Can a teenager make an informed consent to treatment? Questions of this type will be the mainstay of the Center for Pediatric Bioethics, the nation first center for bioethics solely dedicated to pediatrics, which will be located at Childrens Hospital and Regional Medical Center in Seattle.
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Reacting to allegations that clinical trials showing unfavorable results often go unpublished, two states are proposing legislation that would require clinical researchers to register their studies with the NIHs clinical trials database if they involve studies designed to evaluate a drugs safety or effectiveness.
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Researchers are finding the HIPAA to be a significant barrier to recruiting research participants, in part because of the inconsistent way in which IRBs deal with requests for HIPAA waivers.
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The 1999 research-related death of Jesse Gelsinger achieved one more step toward resolution with the announcement of a settlement between the federal government and researchers and research institutions involved in the case.
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A video created to dispel patient misconceptions about clinical trials benefited from a diverse array of viewpoints everyone from physicians and nurses to subjects and even those who decide not to take part in clinical trials, says the woman who spearheaded the effort.