ARTICLE | Regulation
Commentary: Not so fast
Hype overstates risks, potential of FDA Alzheimer's guidance
March 25, 2013 7:00 AM UTC
FDA's new draft guidance on Alzheimer's disease is being alternately hailed as a breakthrough in FDA thinking about how to get new AD drugs to patients faster and attacked as a radical, risky step toward unleashing minimally tested new drugs on a desperate patient population.
Both the hype and the hope are misplaced, as the scientific and regulatory breakthroughs needed to make real progress don't yet exist...