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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Number one ask is for congressional pressure to centralize rare disease expertise at the agency, but advocates also are preparing legislation that would mandate the new center.
A COE modeled after the Oncology Center of Excellence, which stakeholders had proposed, is not in the works, but rather a more virtual structure.
Now most, if not all, assessment divisions within the Office of New Drugs have dealt with issues surrounding small trials and rare diseases, defying common belief that experience was spread unequally.