Posted by Michael Wonder on 15 Sep 2018
Single FDA centre fo rare diseases could be 'negative' to rare disease cause
14 September 2018 - FDA's Center for Drug Evaluation and Research Director Janet Woodcock advised against a single FDA Centre of Excellence for rare diseases.
Woodcock made the remarks while speaking at the EveryLife Foundation for Rare Diseases scientific workshop on Thursday in Washington.
Woodcock argued a single Centre of Excellence would be negative to the rare diseases cause, emphasising the need for a multidisciplinary approach to rare disease product review.
Having a matrix structure where FDA could assemble teams from "clusters of expertise" might suit rare disease product review better, Woodcock said.
