Just hours after Eli Lilly and Company released positive Phase III data for its anti-amyloid Alzheimer’s treatment donanemab on 3 May, US Food and Drug Administration Commissioner Robert Califf was discussing his vision for a new kind of post-market data collection system that could help better pinpoint the people who should be treated with the drug.
It’s unusual for anyone at FDA to be publicly commenting on a drug under development, never mind the commissioner. And it’s particularly interesting given the high-profile and at times controversial...