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What is the FDAs most important focus these days with regard to the clinical trial industry?
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Research into the intricacies of the human genome has opened up a new era for biologic and biomedical research. Investigators are poised to explore the almost unlimited potential to diagnose, treat and possibly cure and prevent many diseases once thought untreatable.
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Obtaining informed consent from people with schizophrenia is a process fraught with difficulty, as the condition can impair a potential research subjects ability to recall the consent information he or she is given.
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Public trust in clinical trial research was damaged in the past year because of conflicts of interest issues that arose with the NIH and by front-page media reports about drugs that had been studied and approved, yet were found later to result in deaths among some people who used them.
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As IRBs move to improve the quality of human subjects protection in international research, they should pursue a model of informed consent that begins long before an individual signs a consent document and continues afterward.
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Behavioral surveys of adolescents always are a delicate proposition, requiring consent from parents as well as assent from the child and asking both to consider the possible implications of participation.
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Baxter Healthcare Corp. in Deerfield, IL, is recalling all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering medication and fluids to patients.
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You think the patient before you suffering from minor acid reflux will respond just fine to over-the-counter antacids, and you tell her so. But before you ever saw her, she had already decided that that purple pill advertised on television is what she needs, and theres no changing her mind.
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A Food and Drug Administration (FDA) advisory committees recommendation that silicone gel breast implants be returned to the United States market after an essential ban of 13 years is being met with approval from some in the medical community and dismay by others.
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Newborns in every state are screened for disorders that, if undetected, could lead to disability or death; but while some states test for nine or more conditions, others test for only one or two. Now, efforts are being made to bring uniformity to testing nationwide and to determine what tests are the most crucial.