Advocating for Congress to Establish a Rare Disease Center of Excellence
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CLS joined the EveryLife Foundation in sending a letter to Congress, advocating for the inclusion of report language to establish an FDA Rare Disease Center of Excellence in the FY2025 appropriations bill. This initiative aims to create a centralized hub within the FDA to coordinate efforts across multiple review divisions, streamline the regulatory process, and address the unique challenges of rare disease drug development, such as small patient populations and dispersed clinical trial sites. The letter emphasizes the critical impact this center would have on accelerating the development of effective treatments for the over 10,000 rare diseases affecting more than 30 million Americans.
Read the full letter here.