Hamburg: FDA regulation not 'one size fits all'

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). ...