Rare Disease Advocates Lobby US Congress For FDA Center of Excellence
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.
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A deputy center director position remains open and four new associate director positions were added over the last year.
President Trump's budget request would boost compounding and vaccines by $5m, but human drugs program would lose $4.8m in training funds.
A COE modeled after the Oncology Center of Excellence, which stakeholders had proposed, is not in the works, but rather a more virtual structure.