Orphan Drugs Compose Majority Of Novel US Approvals For First Time Ever In 2018
Orphan drugs and priority reviews achieved historic highs in CDER's 2018 novel approval class, but share of products with breakthrough therapies took a slide.
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Could Revisiting US Approval Decisions Become Less Rare?
While not identifying specific situations raising potential questions, the FDA commissioner uses his appearance at agency's annual rare disease event to advise regulatory decisions may be revisited as more data becomes available.
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.