Vision in 20/20 (DrugWonks Blog)
“To help reviewers better understand patient perspectives, the FDA will conduct four public meetings per year on different disease areas during the five-year PDUFA cycle,” blogger Peter Pitts writes. This will amount to 20 meetings on 20 different disease areas, Pitts notes. The FDA has developed a list of 39 candidate topics for the meetings and about one-third of them rare diseases. The information gleaned from these sessions is expected to help reviewers better understand patient needs and risk tolerance and to help spur further research, Pitts writes.