Category Archives: Agency Insight
By Ben Comer | Published: May 7, 2013
During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news. On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]
By Ben Comer | Published: April 16, 2013
People tell you who they are, but we ignore it – because we want them to be who we want them to be. – Don Draper At the beginning of the Reboot Camp – held at New York City’s Alexandria Center on April 12 – Intouch Solutions’ CEO Faruk Capan declared the days of Don Draper [...]
By Jill Wechsler | Published: January 30, 2013
The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
By Ben Comer | Published: October 17, 2012
FDA’s head of neurology products told industry execs at the Prix Galien Forum that the agency is open to alternative clinical trial designs in Alzheimer’s disease, and would like to see more combination products in clinical testing.
By Ben Comer | Published: September 6, 2012
Big Pharma’s tin ear for social, user-generated content online is softening despite regulatory anxiety. In the quest to better understand what patients and doctors need, pharma – thanks in part to a bevy of third-party service providers – is beginning to recognize and incorporate insights from social media into their development and commercialization programs, according [...]