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In this issue: FDA issues multiple drug safety alerts; ARBs and cancer risk; and FDA actions.
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As of june 29, 2011, german authorities reported 3,189 cases of entero-hemorrhagic E. coli (EHEC) infections, and 884 other cases have also been identified.
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A 58-year-old liberian-born woman was in excellent general health, living and working in a large academic medical center in Rhode Island for more than 20 years when she developed nonspecific gastrointestinal symptoms and underwent endoscopy, which revealed Strongyloides stercoralis larvae on a duodenal biopsy in March 2010.
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The clinical research industry has hit another economic low point as the economy continues to falter and there is little chance of further economic stimulus money for research through a renewal of the American Recovery and Reinvestment Act of 2009 (ARRA).
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Finding qualified and high-performing clinical trial workers who can work harder under more challenging circumstances takes patience and time.
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Clinical trial managers have to toe the line between asking more of their staff, which might be greatly reduced during the continued economic downturn, and retaining employees and maintaining morale.
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Regulatory authorities in both the United States and Canada have been focusing on investigator oversight, an area in which clinical trial sites could have serious issues if their documentation is lacking.
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Clinical trial sites frequently make mistakes when conducting the informed consent process with prospective study participants, a compliance expert says.
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The Office for Human Research Protections announced in late June, 2011, the selection of four new members of the Secretary's Advisory Committee for Human Research Protections (SACHRP).
