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New CDC Report on Alarming Rates of Antibiotic-Resistant Infections

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Every year in the United States, 2 million people acquire an antibiotic-resistant infection. Of those, at least 23,000 die as a result. That’s according to an alarming report  released last week by the CDC. Antibiotic resistance is one of the largest threats to global health. The prevalence of antibiotic-resistant infections is not only a serious world-wide public health issue, it also adds considerable costs to the U.S. healthcare system. According to the CDC: Studies have estimated Read More >

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Putting Patients First: Paving a Path to Useful CER

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Comparative effectiveness research (CER) has the potential to improve health outcomes by helping people make better-informed decisions. But how do we know that CER will generate information that is useful? On September 30, in Washington, DC, you can be part of a conversation featuring a broad range of health care stakeholders—patients, providers, policymakers, payers, researchers, and those who fund research–by participating in an effort led by the National Health Council to create a framework to Read More >

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FDA Consumer Update: Advances in Saving Lives with Blood

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Every two seconds in the U.S., someone needs a blood transfusion or blood product—people of all ages who are injured, need surgery or who are suffering from illness. The Food and Drug Administration’s primary responsibility with regard to blood and blood products is to assure the safety of patients who receive these life-saving products. In this interview, Richard Davey, M.D., director of the Division of Blood Applications, Office of Blood Research and Review at FDA Read More >

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Exploring New Solutions For Neglected Diseases in Developing Countries

SBIR Reauthorization Moves Forward

On Tuesday, BIO Ventures for Global Health (BVGH) announced the completion of the 30th research agreement as part of its partnership with the World Intellectual Property Organization (WIPO) to better enable drug companies to assist researchers in addressing infectious diseases worldwide. The partnership aims to accelerate development of drugs, diagnostics and vaccines for more than 1.5 billion people suffering from malaria, tuberculosis, and other neglected tropical diseases including dengue in developing nations. A recent publication in Read More >

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CTTI: Use of Central IRBs in Multi-Center Trials to Streamline Clinical Research

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Multi-center clinical trials can provide high-quality, statistically-sound evidence to answer medical questions. Earlier this year, the Clinical Trials Transformation Initiative (CTTI) launched a new tool and provided recommendations to improve the efficiency and quality of multi-center clinical trials. Typically, each participating center submits the study protocol to its institutional review board (IRB). Thus in a multi-center trial, the same protocol is submitted to as many IRBs as there are sites. The process of multiple reviews Read More >

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