FDA sets up Rare Diseases Innovation Hub

On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER).

The FDA Rare Disease Innovation Hub (the Hub) is an FDA cross-center program that will act as the single point of engagement and connection with outside parties for drug and biological product development and as a forum for CBER and CDER to collaborate on cross-cutting rare disease-related issues. Through the Hub, we plan to foster a community at the FDA for open dialogue and knowledge sharing to identify new approaches to drug and biologic development and overcome hurdles that have traditionally impeded progress for rare disease treatments.

Dr Cavazzoni said: “Through the Hub, we plan to foster a community at the FDA for open dialogue and knowledge sharing to identify new approaches to drug and biologic development and overcome hurdles that have traditionally impeded progress for rare disease treatments.