Drug Approvals Take Customized Approach Based on Disease
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Drugmakers can gain U.S. approval for medicines based on a wide variety of evidence the treatments work and are safe, including a single clinical trial, researchers said.
Almost as many novel drugs approved from 2005 to 2012 were based on one study as those using two clinical trials, an analysis in the Journal of the American Medical Association found. Researchers from Yale University’s School of Medicine reviewed 188 novel therapies approved by the Food and Drug Administration for 206 uses during the time period.