US FDA Plans Rare Disease Center Of Excellence, But Not "That" Kind Of COE
A COE modeled after the Oncology Center of Excellence, which stakeholders had proposed, is not in the works, but rather a more virtual structure.
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Waiting for paper letters to arrive can delay drug development, companies contend, but moving completely to e-communication may be difficult for the FDA.
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.
Acting Commissioner Giroir Emphasizes 'Transitional' Period, Suggesting Time At US FDA Will Be Short
Giroir's memo to FDA staff also says intends to coordinate with prior acting commissioner Norman Sharpless to ensure current activities continue.