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FDA Voices: FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub

Today, FDA published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research (CDER) and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research (CBER).

This summer, we announced plans to establish the Rare Disease Innovation Hub (the Hub), and today, Drs. Cavazzoni and Marks share more about our progress. 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. 

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