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Hamburg: FDA regulation not 'one size fits all'

February 7, 2014 1:55 AM UTC

FDA Commissioner Margaret Hamburg defended the agency's flexibility during the drug development and approval process and said she "would be more troubled if FDA used a rigid, 'one size fits all' approach." Hamburg's comments came in a blog Sirturo bedaquiline from Johnson & Johnson (NYSE:JNJ) was based on a single study and a surrogate marker instead of "improved health and wellness" in patients and that "availability through compassionate use would appear to be a more reasonable approach" (see BioCentury, Feb. 25, 2013). ...