Califf: Work needed to define patient-FDA boundaries

FDA Commissioner Robert Califf expressed strong support Friday for patient groups engaging with FDA, and said more work needs to be done to define the rules of engagement.

"If I had a disease, I would not want to have a disease that had an ineffective patient advocacy group or a review group at FDA that was not tuned in to my disease," Califf said at a meeting co-sponsored by Friends of Cancer Research. Effective patient advocacy is important because it helps "get industry to the right place so the products they bring forward are the right ones, solving the right problems, with the right endpoints that really matter to the patients," he said...