USA – FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub

FDA

This summer, the U.S. Food and Drug Administration announced plans to establish the Rare Disease Innovation Hub (the Hub), and today, we are excited to 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 the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (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.