Article: PPD Awarded U.S. Food and Drug Administration Contract to Evaluate FDA's Spontaneous Adverse Event Surveillance System.

Article: Preventing compelled disclosure of adverse event ...
Defense Counsel Journal;  January 1, 1996 ;     700+ words ... ... and device manufacturers to produce adverse drug reaction or product experience reports ... any other person associated with an adverse event involving a human drug, biologic ... Federal statute or regulation to make adverse event reports. Disclosure of the identities ...

Article: Studies from Sanofi Aventis provide new data on adverse ...
Biotech Week;  December 17, 2008 ;     700+ words ... ... treatment emergent adverse event analyses' new findings in adverse drug reactions. According ... analysis for adverse event (AE) safety ... Aventis (see also Adverse Drug Reactions ... treatment emergent adverse event analyses. Statistics ...

Article: New findings from A.M. Hochberg and co-authors in the area of ...
Medical Letter on the CDC & FDA;  May 17, 2009 ;     700+ words ... ... Drug-versus-drug adverse event rate comparisons: a pilot ... on data from the US FDA Adverse Event Reporting System' new findings in adverse drug reactions. "A number of published studies compare adverse event rates for drugs on the ...

Article: Trends in hospital admissions for adverse drug ...
BMC Clinical Pharmacology;  September 25, 2007 ;     700+ words ... ... marketed, detection of adverse drug reactions generally depends ... recognized ADRs notification of adverse drug reactions from such spontaneous ... between the drug and the adverse event is unknown [7]. Hence, many adverse drug reactions do not become ...

Article: Studies from J.C. Dowdy et al add new findings in the area of ...
Biotech Week;  August 5, 2009 ;     700+ words ... ... evaluation of FDA adverse event reporting data,' new data in adverse drug reactions. According ... colleagues, (see also Adverse Drug Reactions ... evaluation of FDA adverse event reporting data ... States, Cordova, Adverse Drug Reactions, Adverse ...

Article: Research data from D.D. Sin and colleagues update understanding ...
Biotech Week;  September 30, 2009 ;     700+ words ... ... test 0.94) or a serious adverse event (0.61). Increasing age ... occurrence of pneumonia as an adverse event or a serious adverse event," wrote D.D. Sin and colleagues (see also Adverse Drug Reactions). The researchers ...

Article: Tufts University publishes research in adverse drug ...
Medical Letter on the CDC & FDA;  August 23, 2009 ;     700+ words ... ... rates of cancer adverse event reports filed ... report (see also Adverse Drug Reactions). "We tabulated all adverse event reports listing ... relative to all adverse event reports were ... States, Box, Adverse Drug Reactions, Adverse ...