Center Of Excellence Not Best Model For US FDA Rare Disease Program, Woodcock Says
Center for Drug Evaluation and Research Director says rare disease reviews need multiple specialists, which likely would not fit into a centralized rare disease review group.
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‘Umbrella’ program is intended to ensure all rare disease and related programs at CDER are working together, which seems similar to the rare disease center of excellence concept that stakeholders want to coordinate activities across the FDA.
Rare Disease Challenges At US FDA: CDER Director Says More Staff, Not Reorganization, Will Fix Issues
Rather than changing the agency's structure to create more focus on rare diseases, Patrizia Cavazzoni wants funding for people to do the necessary work.
Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan
The two new intercenter institutes, one to focus on a common group of diseases and the other on rare diseases, appear to be unfunded mandates, which could hinder the agency’s ability to get them up and running.