ASF and FAST applaud the FDA’s recent announcement regarding the establishment of a Rare Disease Innovation Hub. The Hub is an intercenter collaboration to address common scientific, clinical, and policy issues related to rare disease product development, including relevant cross-disciplinary approaches related to product review, and promote consistency across offices and Centers.
FAST and ASF have long supported efforts by the EveryLife Foundation for Rare Diseases toward establishing a new FDA rare disease infrastructure to enhance and streamline their existing processes and optimizing and facilitating the coordination of the extensive rare disease expertise across the FDA.
Both organizations have joined past advocacy efforts to push for creating such a center, including a recent letter submitted by EveryLife, signed by over 100 organizations, including ASF and FAST.
FDA announced the first public meeting for the new FDA Rare Disease Innovation Hub will happen on October 16th from 10 am - 1 pm EST at the FDA's White Oak campus. A live stream will be available, and written comments will be accepted until October 31st.
Prior registration is required. ASF and FAST will be in attendance.