The FDA's New New Drug Safety Reporting Plan

Law360, New York (October 14, 2010, 12:17 PM EDT) -- On Sept. 28, 2010, the U.S. Food and Drug Administration issued a final rule governing the safety analysis and reporting requirements for drugs under clinical investigation, even after they are on the market. Citing the European model and seeking greater harmonization with international standards, the FDA defined new terms and revised old terms. Among its goals: to improve patient safety by limiting the number of adverse reaction reports it receives and increasing the usefulness of each report.

Greater safety by fewer reports? This is a paradox,...
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