21st Century Bioequivalence: How do you spell "Integrity?"

Much discussion about pharmaceutical quality at the FDA of late (Drug Quality: If you can’t measure it, it doesn’t count, The silent “n” of PDUFA) – and specifically about a more 21st century view of bioequivalence. And appropriately so. But is the agency doing the right thing the right way? Consider Concerta. Will the courts follow the chevron deference route or tell the FDA to put it on paper?
Source: drugwonks.com Blog - Category: Pharmaceuticals Source Type: blogs