The Food and Drug Administration (FDA) is doing a better job of appropriately weighing the evidence from noninferiority trials when considering approval of a new drug, said the Government Accountability Office (GAO) in an August 30 report (http://www.gao.gov/new.items/d10798.pdf).
Some critics have argued that a noninferiority drug trial, which is designed to determine if a drug candidate is as effective as an established treatment for a medical condition, is difficult to design and interpret. Because of this, they say, such trials may provide pharmaceutical manufacturers an easier avenue for getting approval to market a drug that may be less safe or efficacious than one already in use. In March, the FDA issued guidance for industry, explaining what the agency would consider proper noninferiority trials for drug approval.
The GAO report said its review of FDA guidance “showed that the agency has become more conservative in allowing evidence from noninferiority trials to demonstrate a drug's effectiveness” by limiting indications for which such trials may be used and by becoming more rigorous in reviewing evidence from these studies.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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