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US FDA Doesn't Support Creating Ultra-Orphan Designation

 
• By Derrick Gingery

Agency is already approving drugs for diseases with much smaller patient populations than the traditional rare disease, officials note.

FDA entrance sign 2016

The US FDA does not seem too interested in further subdividing the size of orphan diseases to create more incentives.

The so-called ultra-rare space, much smaller than a traditional rare disease, which FDA defines as affecting fewer than 200,000 people, is gaining attention as the science improves to attack the...

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