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FDA Keeps Brand-Name Drugs On A Fast Path To Market ― Despite Manufacturing Concerns

After unanimously voting to recommend a miraculous hepatitis C drug for approval in 2013, a panel of experts advising the Food and Drug Administration gushed about what they’d accomplished. “I voted ‘yes’ because, quite simply, this is a game changer,” National Institutes of Health hepatologist Dr. Marc Ghany said of Sovaldi, Gilead Science’s new pill designed to cure most cases of hepatitis C within 12 weeks. Dr. Lawrence Friedman, a professor at Harvard Medical School, called it his “favorite vote” as an FDA reviewer, according to the transcript. What the panelists didn’t know was that the FDA’s drug quality inspectors had recommen...

Read the full post at Syndicate – Kaiser Health News
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